N/A
N=38
Strength Training for Skeletal Muscle Adaptation After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00827827 ↗Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Jan 2015
Primary outcome: Primary: Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side) — 126.1; 11.3 lbs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise- Strength Training (Other); Exercise- Stretching Control (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side) |
126.1; 11.3 | — |
| PRIMARY Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side) |
93.2; 22.7 | — |
| PRIMARY Change in 1-RM Muscle Strength (Leg Extension, Paretic Side) |
28.6; 3.4 | — |
| PRIMARY Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side) |
20.8; 0.4 | — |
| PRIMARY Change in Leg Muscle Endurance (Paretic Side) |
27.4; 2.0 | — |
| PRIMARY Change in Leg Muscle Endurance (Non-Paretic Side) |
27.5; 1.8 | — |
| PRIMARY Change in 6-minute Walk Distance |
132.3; -2.1 | — |
| PRIMARY Change in 10 Meter Walking Speed (Self-Selected) |
0.16; 0.03 | — |
| PRIMARY Change in 10 Meter Walking Speed (Fastest) |
0.24; 0.09 | — |
| PRIMARY Change in Peak Aerobic Capacity (VO2 Peak) |
1.2; -0.4 | — |
| PRIMARY Change in Berg Balance Scale |
0.3; -0.1 | — |
| PRIMARY Change in Paretic Limb Step Time (Self-Selected) |
-0.04; -0.03 | — |
| PRIMARY Change in Paretic Limb Step Time (Fastest) |
0.00; 0.00 | — |
| PRIMARY Change in Non-Paretic Limb Step Time (Self-Selected) |
-0.01; -0.07 | — |
| PRIMARY Change in Non-Paretic Limb Step Time (Fastest) |
-0.01; -0.01 | — |
| PRIMARY Change in Paretic Limb Step Length (Self-Selected) |
4.0; 1.1 | — |
| PRIMARY Change in Paretic Limb Step Length (Fastest) |
3.8; 0.9 | — |
| PRIMARY Change in Non-Paretic Limb Step Length (Self-Selected) |
3.8; 0.3 | — |
| PRIMARY Change in Non-Paretic Limb Step Length (Fastest) |
4.6; -0.4 | — |
Summary
Chronically disabled stroke survivors experience accelerated skeletal muscle atrophy and other detrimental changes to muscle and surrounding tissues on the paretic side. This unilateral tissue-level damage contributes to worsening disability and insulin resistance. This VA Merit Award will advance the investigators' understanding of the potential for strength training (ST) to reverse stroke-related muscle abnormalities to improve metabolic health, strength, and function. It will be the first study to thoroughly investigate the effects of ST on muscle atrophy, intramuscular fat, muscle fiber characteristics, capillary density and insulin sensitivity after stroke.
Eligibility Criteria
Inclusion Criteria
- Stroke greater than 6 months prior with residual hemiparetic gait in women or men aged 40-85 years
- Completion of all regular post-stroke physical therapy
- Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent
Exclusion Criteria
- Alcohol consumption greater than 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report
- clinical history of:
- unstable angina
- recent (less than 3 months) myocardial infarction or congestive heart failure (NYHA category II)
- hemodynamically significant valvular dysfunction
- peripheral arterial occlusive disease (PAOD) with claudication
- major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise
- pulmonary or renal failure
- poorly controlled hypertension (greater than 190/110)
- recent hospitalization for severe disease or surgery
- severe or global receptive aphasia which confounds reliable testing and training
- Allergy to lidocaine
- Known muscle disorder
- Taking Coumadin or Lovenox (contraindication for muscle biopsies)
- Dementia
- Untreated major depression
Data sourced from ClinicalTrials.gov (NCT00827827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.