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Strength Training for Skeletal Muscle Adaptation After Stroke

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ClinicalTrials.gov Identifier: NCT00827827
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : January 19, 2015
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Other: Exercise- Strength Training
Other: Exercise- Stretching Control
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Period Title: Overall Study
Started 22 16
Completed 14 16
Not Completed 8 0
Reason Not Completed
Lost to Follow-up             3             0
Fall at home- hospitalization             1             0
Another cerebrovascular accident (CVA)             1             0
Gout             1             0
Transportation issues             1             0
Burned with water at home             1             0
Arm/Group Title Strength Training Stretching Control Total
Hide Arm/Group Description

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Total of all reporting groups
Overall Number of Baseline Participants 22 16 38
Hide Baseline Analysis Population Description
Disabled stroke survivors
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 16 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  86.4%
14
  87.5%
33
  86.8%
>=65 years
3
  13.6%
2
  12.5%
5
  13.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 16 participants 38 participants
56.9  (11.5) 55.2  (8.7) 56.2  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 16 participants 38 participants
Female
6
  27.3%
4
  25.0%
10
  26.3%
Male
16
  72.7%
12
  75.0%
28
  73.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 16 participants 38 participants
22 16 38
1.Primary Outcome
Title Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom strength measurements were recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: lbs
126.1  (22.2) 11.3  (14.6)
2.Primary Outcome
Title Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom strength measurements were recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: lbs
93.2  (26.1) 22.7  (16.4)
3.Primary Outcome
Title Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)
Hide Description [Not Specified]
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom strength measurements were recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: lbs
28.6  (4.3) 3.4  (2.4)
4.Primary Outcome
Title Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)
Hide Description [Not Specified]
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom strength measurements were recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 16
Mean (Standard Error)
Unit of Measure: lbs
20.8  (0.4) 0.4  (2.6)
5.Primary Outcome
Title Change in Leg Muscle Endurance (Paretic Side)
Hide Description Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom muscle endurance measurements were recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: repetitions
27.4  (4.5) 2.0  (2.1)
6.Primary Outcome
Title Change in Leg Muscle Endurance (Non-Paretic Side)
Hide Description Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom muscle endurance measurements were recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: repetitions
27.5  (5.0) 1.8  (1.8)
7.Primary Outcome
Title Change in 6-minute Walk Distance
Hide Description [Not Specified]
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom 6-minute walk distance was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Controls
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 16
Mean (Standard Error)
Unit of Measure: feet
132.3  (48.3) -2.1  (21.6)
8.Primary Outcome
Title Change in 10 Meter Walking Speed (Self-Selected)
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Controls
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: meters/ second
0.16  (0.09) 0.03  (0.06)
9.Primary Outcome
Title Change in 10 Meter Walking Speed (Fastest)
Hide Description [Not Specified]
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Controls
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 14
Mean (Standard Error)
Unit of Measure: meters/ second
0.24  (0.10) 0.09  (0.08)
10.Primary Outcome
Title Change in Peak Aerobic Capacity (VO2 Peak)
Hide Description [Not Specified]
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months
Arm/Group Title Strength Training Stretching Controls
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: mls/kg/min
1.2  (0.6) -0.4  (0.5)
11.Primary Outcome
Title Change in Berg Balance Scale
Hide Description This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points. Range is 0-56 and higher values represent a better outcome.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom a Berg Score was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: Scores on a scale
0.3  (0.6) -0.1  (0.5)
12.Primary Outcome
Title Change in Paretic Limb Step Time (Self-Selected)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 11
Mean (Standard Error)
Unit of Measure: seconds
-0.04  (0.03) -0.03  (0.03)
13.Primary Outcome
Title Change in Paretic Limb Step Time (Fastest)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 10
Mean (Standard Error)
Unit of Measure: seconds
0.00  (0.03) 0.00  (0.02)
14.Primary Outcome
Title Change in Non-Paretic Limb Step Time (Self-Selected)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 11
Mean (Standard Error)
Unit of Measure: seconds
-0.01  (0.02) -0.07  (0.05)
15.Primary Outcome
Title Change in Non-Paretic Limb Step Time (Fastest)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 10
Mean (Standard Error)
Unit of Measure: seconds
-0.01  (0.02) -0.01  (0.01)
16.Primary Outcome
Title Change in Paretic Limb Step Length (Self-Selected)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 11
Mean (Standard Error)
Unit of Measure: cm
4.0  (1.5) 1.1  (2.8)
17.Primary Outcome
Title Change in Paretic Limb Step Length (Fastest)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 10
Mean (Standard Error)
Unit of Measure: cm
3.8  (2.1) 0.9  (2.7)
18.Primary Outcome
Title Change in Non-Paretic Limb Step Length (Self-Selected)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 11
Mean (Standard Error)
Unit of Measure: cm
3.8  (1.4) 0.3  (2.1)
19.Primary Outcome
Title Change in Non-Paretic Limb Step Length (Fastest)
Hide Description This and other measures come from Instrumented Walkway (Gait Rite)
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom measurement was recorded at Baseline and 3 months
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description:

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Overall Number of Participants Analyzed 13 10
Mean (Standard Error)
Unit of Measure: cm
4.6  (1.9) -0.4  (3.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Strength Training Stretching Control
Hide Arm/Group Description

Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.

Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.

Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises

All-Cause Mortality
Strength Training Stretching Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Strength Training Stretching Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      2/16 (12.50%)    
General disorders     
fell at home [1]  1/22 (4.55%)  1 1/16 (6.25%)  1
hypotensive episode [2]  1/22 (4.55%)  1 0/16 (0.00%)  0
choked on a pill at home [3]  0/22 (0.00%)  0 1/16 (6.25%)  1
[1]
required hospitalization.
[2]
following a training session. Further evaluation indicated the need for hospital admission.
[3]
went to the ER where he was held overnight
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Strength Training Stretching Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/22 (13.64%)      9/16 (56.25%)    
General disorders     
hypotensive event [1]  1/22 (4.55%)  1 2/16 (12.50%)  2
falls outside of training/ testing sessions [2]  0/22 (0.00%)  0 5/16 (31.25%)  5
muscle strain [1]  1/22 (4.55%)  1 1/16 (6.25%)  1
gout flare-up [3]  0/22 (0.00%)  0 1/16 (6.25%)  1
adverse reaction to lidocaine during muscle biopsy [4]  1/22 (4.55%)  1 0/16 (0.00%)  0
[1]
not requiring hospitalization
[2]
none requiring hospitalization
[3]
no hospitalization but treated by PCP
[4]
symptoms resolved after 40 minutes

Scanning results and muscle biopsy outcomes are still pending and won't be available for some time.

Numbers of participants qualifying for and agreeing to metabolic testing will be too low to yield reportable results.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Frederick M. Ivey
Organization: Baltimore VAMC
Phone: 410-375-8419
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00827827     History of Changes
Other Study ID Numbers: B6737-R
H30631 ( Other Identifier: Baltimore VAMC )
First Submitted: January 22, 2009
First Posted: January 23, 2009
Results First Submitted: December 29, 2014
Results First Posted: January 19, 2015
Last Update Posted: July 9, 2018