Strength Training for Skeletal Muscle Adaptation After Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00827827
First received: January 22, 2009
Last updated: January 12, 2015
Last verified: January 2015
Results First Received: December 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Interventions: Other: Exercise- Strength Training
Other: Exercise- Stretching Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Strength Training

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.

Stretching Control

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


Participant Flow:   Overall Study
    Strength Training     Stretching Control  
STARTED     22     16  
COMPLETED     14     16  
NOT COMPLETED     8     0  
Lost to Follow-up                 3                 0  
Fall at home- hospitalization                 1                 0  
Another CVA                 1                 0  
Gout                 1                 0  
Transportation issues                 1                 0  
Burned with water at home                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Disabled stroke survivors

Reporting Groups
  Description
Strength Training

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.

Stretching Control

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 Total of all reporting groups

Baseline Measures
    Strength Training     Stretching Control     Total  
Number of Participants  
[units: participants]
  22     16     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     14     33  
>=65 years     3     2     5  
Age  
[units: years]
Mean ± Standard Deviation
  56.9  ± 11.5     55.2  ± 8.7     56.2  ± 10.3  
Gender  
[units: participants]
     
Female     6     4     10  
Male     16     12     28  
Region of Enrollment  
[units: participants]
     
United States     22     16     38  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in 1-RM Muscle Strength (Leg Press, Paretic Side)   [ Time Frame: Baseline, 3 months ]

2.  Primary:   Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)   [ Time Frame: Baseline, 3 months ]

3.  Primary:   Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)   [ Time Frame: Baseline, 3 Months ]

4.  Primary:   Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)   [ Time Frame: Baseline, 3 Months ]

5.  Primary:   Change in Leg Muscle Endurance (Paretic Side)   [ Time Frame: Baseline, 3 Months ]

6.  Primary:   Change in Leg Muscle Endurance (Non-Paretic Side)   [ Time Frame: Baseline, 3 months ]

7.  Primary:   Change in 6-minute Walk Distance   [ Time Frame: Baseline, 3 Months ]

8.  Primary:   Change in 10 Meter Walking Speed (Self-Selected)   [ Time Frame: Baseline, 3 months ]

9.  Primary:   Change in 10 Meter Walking Speed (Fastest)   [ Time Frame: Baseline, 3 Months ]

10.  Primary:   Change in Peak Aerobic Capacity (VO2 Peak)   [ Time Frame: Baseline, 3 Months ]

11.  Primary:   Change in Berg Balance Scale   [ Time Frame: Baseline, 3 months ]

12.  Primary:   Change in Paretic Limb Step Time (Self-Selected)   [ Time Frame: Baseline, 3 months ]

13.  Primary:   Change in Paretic Limb Step Time (Fastest)   [ Time Frame: Baseline, 3 Months ]

14.  Primary:   Change in Non-Paretic Limb Step Time (Self-Selected)   [ Time Frame: Baseline, 3 months ]

15.  Primary:   Change in Non-Paretic Limb Step Time (Fastest)   [ Time Frame: Baseline, 3 Months ]

16.  Primary:   Change in Paretic Limb Step Length (Self-Selected)   [ Time Frame: Baseline, 3 Months ]

17.  Primary:   Change in Paretic Limb Step Length (Fastest)   [ Time Frame: Baseline, 3 months ]

18.  Primary:   Change in Non-Paretic Limb Step Length (Self-Selected)   [ Time Frame: Baseline, 3 Months ]

19.  Primary:   Change in Non-Paretic Limb Step Length (Fastest)   [ Time Frame: Baseline, 3 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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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
e-mail: fivey@grecc.umaryland.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00827827     History of Changes
Other Study ID Numbers: B6737-R, H30631
Study First Received: January 22, 2009
Results First Received: December 29, 2014
Last Updated: January 12, 2015
Health Authority: United States: Federal Government