We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387712
First Posted: October 13, 2006
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: February 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stroke
Inflammation
Interventions: Other: Velocity based treadmill training
Other: Duration based treadmill training

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Veterans with chronic hemiparetic stroke (latency > 6 months) were recruited from the Baltimore VA and University of Maryland Neurology and Primary care clinics, as well as through Institutional Review Board approved flyers and ads.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Reasons for participant exclusion were not meeting eligibility criteria, screen failures (ischemia on stress test or serious lab abnormalities) new medical conditions, study time requirements, return to work, lost to follow-up, lack of transportation.

Reporting Groups
  Description
Velocity Based Treadmill Training 6-month treadmill exercise progressed on speed based on individual participant's tolerance, abilities and safety.
Duration Based Treadmill Training 6-month treadmill exercise at self-selected speed progressed only on training duration.

Participant Flow:   Overall Study
    Velocity Based Treadmill Training   Duration Based Treadmill Training
STARTED   47   52 
COMPLETED   18   16 
NOT COMPLETED   29   36 
Physician Decision                6                4 
Lost to Follow-up                17                20 
Withdrawal by Subject                6                12 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Velocity Based Treadmill Training 6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
Duration Based Treadmill Training 6-month treadmill exercise at self-selected speed progressed only on training duration.
Total Total of all reporting groups

Baseline Measures
   Velocity Based Treadmill Training   Duration Based Treadmill Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   52   99 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  14.9%      10  19.2%      17  17.2% 
>=65 years      40  85.1%      42  80.8%      82  82.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (3)   64  (6)   63  (3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  23.4%      14  26.9%      25  25.3% 
Male      36  76.6%      38  73.1%      74  74.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
African American      28  59.6%      32  61.5%      60  60.6% 
Latino      3   6.4%      1   1.9%      4   4.0% 
Caucasian      16  34.0%      19  36.5%      35  35.4% 
Region of Enrollment 
[Units: Participants]
     
United States   47   52   99 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cardiovascular Fitness (VO2 Peak)   [ Time Frame: Baseline to 6 month ]

2.  Primary:   Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a   [ Time Frame: Baseline to 6 month ]

3.  Secondary:   30 Foot Walk Time (Sec)   [ Time Frame: baseline to 6 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Limitations of the study, such as early termination, led to smaller numbers of participants analyzed and technical problems with measurement and participant inability to attend testing or complete testing led to unreliable and missing data.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Charlene Hafer-Macko
Organization: Baltimore VAMC
phone: 410-605-7000 ext 5451
e-mail: charlene.hafer-macko@va.gov


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00387712     History of Changes
Other Study ID Numbers: B3834-R
First Submitted: October 12, 2006
First Posted: October 13, 2006
Results First Submitted: February 21, 2017
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017