Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H30631 | Other Identifier | Baltimore VAMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study investigates the hypothesis that a novel, high intensity, high repetition ST program will improve abnormalities in paretic and non-paretic leg muscle volume and composition compared to an attention-matched control regimen of supervised stretching over a 3-month intervention period in those disabled by stroke. The investigators further hypothesize that ST-induced skeletal muscle adaptation will translate into improved insulin sensitivity, strength, and function in this population. The specific objectives are to: 1) Determine the effects ST compared to a control intervention on paretic and non-paretic abnormalities in skeletal muscle volume, intramuscular fat, muscle fiber distribution, muscle capillary density, and muscle inflammation in chronically disabled stroke survivors. 2) Determine the effects ST compared to a control intervention on insulin sensitivity in stroke survivors, and whether structural and cellular skeletal muscle mechanisms contribute to improvements in insulin sensitivity after ST. 3) Determine the effects ST compared to a control intervention on physical function (strength, walking speed and balance) in stroke survivors, and whether structural skeletal muscle mechanisms predict ST-induced functional improvement.
The project design consists of 4 phases over 5 months for stroke participants enrolled in either of the two intervention arms (ST vs. CONTROL). During phase 1 the investigators will screen and consent chronic stroke patients with residual gait deficits. Phase 2 (3 weeks) will consist of baseline testing that includes dual energy X-ray absorptiometry (DEXA) scanning, bilateral CT scanning of the legs, bilateral vastus lateralis muscle biopsies, strength testing, timed walks, balance measurements, oral glucose tolerance testing, and hyperglycemic clamp testing. Following completion of baseline testing, volunteers are to be randomized to ST or the CONTROL group. Phase 3 (Intervention Phase, 3 months) will begin with 2 sessions of acclimatization for those assigned to the ST group. ST will then be progressed to 2 sets of 20 repetitions on each leg on each machine (Keiser Leg Press, Leg Extension, Leg Curl) with gradual increases in resistance over 3 months. Those in the CONTROL group will receive equal exposure to health care personnel in the Baltimore VA Exercise facility, performing a full battery of upper and lower body passive and active stretching exercises at each intervention session. In Phase 4 all baseline testing and laboratory analyses will be repeated.
Developing evidence-based therapies to combat skeletal muscle deterioration is highly relevant for chronically disabled stoke survivors. There is mounting evidence that current models of post-stroke rehabilitation are not optimal for maximizing recovery of muscle mass, strength, and metabolic health. The proposed research will develop new insight into the utility of progressive ST for reversing detrimental changes to gross muscle composition, muscle molecular phenotype, muscle inflammation, and muscle capillarization. Changes to any or all of these muscle parameters should have measurable impact on both whole body insulin sensitivity and function. Collectively, the results from this trial may change the current standard of care for stroke survivors by providing evidenced reasons for augmenting physical therapists' treatments, allowing more intense and diverse therapy sessions for maintenance of skeletal muscle.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
|
| Arm 2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise- Strength Training | Other | 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side) | Baseline, 3 months | |
| Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side) | Baseline, 3 months | |
| Change in 1-RM Muscle Strength (Leg Extension, Paretic Side) | Baseline, 3 Months | |
| Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side) | Baseline, 3 Months | |
| Change in Leg Muscle Endurance (Paretic Side) | 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). | Baseline, 3 Months |
| Change in Leg Muscle Endurance (Non-Paretic Side) | 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). | Baseline, 3 months |
| Change in 6-minute Walk Distance | Baseline, 3 Months | |
| Change in 10 Meter Walking Speed (Self-Selected) | Baseline, 3 months | |
| Change in 10 Meter Walking Speed (Fastest) |
Not provided
Not provided
Inclusion Criteria:
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:
Allergy to lidocaine
Known muscle disorder
Taking Coumadin or Lovenox (contraindication for muscle biopsies)
Dementia
Untreated major depression
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederick M Ivey, PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27865696 | Result | Ivey FM, Prior SJ, Hafer-Macko CE, Katzel LI, Macko RF, Ryan AS. Strength Training for Skeletal Muscle Endurance after Stroke. J Stroke Cerebrovasc Dis. 2017 Apr;26(4):787-794. doi: 10.1016/j.jstrokecerebrovasdis.2016.10.018. Epub 2016 Nov 16. | |
| 23352685 | Result | Ivey FM, Ryan AS. Resistive training improves insulin sensitivity after stroke. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):225-9. doi: 10.1016/j.jstrokecerebrovasdis.2012.12.014. Epub 2013 Jan 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Disabled stroke survivors
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side) | All participants for whom strength measurements were recorded at Baseline and 3 months | Posted | Mean | Standard Error | lbs | Baseline, 3 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fell at home | General disorders | required hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotensive event | General disorders | not requiring hospitalization |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederick M. Ivey | Baltimore VAMC | 410-375-8419 | fivey@grecc.umaryland.edu |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exercise- Stretching Control | Other | 3x per week upper and lower body stretching mixed with active and passive range of motion exercises |
|
| Baseline, 3 Months |
| Change in Peak Aerobic Capacity (VO2 Peak) | Baseline, 3 Months |
| Change in Berg Balance Scale | 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. | Baseline, 3 months |
| Change in Paretic Limb Step Time (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 months |
| Change in Paretic Limb Step Time (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 Months |
| Change in Non-Paretic Limb Step Time (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 months |
| Change in Non-Paretic Limb Step Time (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 Months |
| Change in Paretic Limb Step Length (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 Months |
| Change in Paretic Limb Step Length (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 months |
| Change in Non-Paretic Limb Step Length (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 Months |
| Change in Non-Paretic Limb Step Length (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | Baseline, 3 Months |
| Another cerebrovascular accident (CVA) |
|
| Gout |
|
| Transportation issues |
|
| Burned with water at home |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
|
| Primary | Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side) | All participants for whom strength measurements were recorded at Baseline and 3 months | Posted | Mean | Standard Error | lbs | Baseline, 3 months |
|
|
|
| Primary | Change in 1-RM Muscle Strength (Leg Extension, Paretic Side) | All participants for whom strength measurements were recorded at Baseline and 3 months | Posted | Mean | Standard Error | lbs | Baseline, 3 Months |
|
|
|
| Primary | Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side) | All participants for whom strength measurements were recorded at Baseline and 3 months | Posted | Mean | Standard Error | lbs | Baseline, 3 Months |
|
|
|
| Primary | Change in Leg Muscle Endurance (Paretic Side) | 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). | All participants for whom muscle endurance measurements were recorded at Baseline and 3 months | Posted | Mean | Standard Error | repetitions | Baseline, 3 Months |
|
|
|
| Primary | Change in Leg Muscle Endurance (Non-Paretic Side) | 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). | All participants for whom muscle endurance measurements were recorded at Baseline and 3 months | Posted | Mean | Standard Error | repetitions | Baseline, 3 months |
|
|
|
| Primary | Change in 6-minute Walk Distance | All participants for whom 6-minute walk distance was recorded at Baseline and 3 months | Posted | Mean | Standard Error | feet | Baseline, 3 Months |
|
|
|
| Primary | Change in 10 Meter Walking Speed (Self-Selected) | All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months | Posted | Mean | Standard Error | meters/ second | Baseline, 3 months |
|
|
|
| Primary | Change in 10 Meter Walking Speed (Fastest) | All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months | Posted | Mean | Standard Error | meters/ second | Baseline, 3 Months |
|
|
|
| Primary | Change in Peak Aerobic Capacity (VO2 Peak) | All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months | Posted | Mean | Standard Error | mls/kg/min | Baseline, 3 Months |
|
|
|
| Primary | Change in Berg Balance Scale | 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. | All participants for whom a Berg Score was recorded at Baseline and 3 months | Posted | Mean | Standard Error | Scores on a scale | Baseline, 3 months |
|
|
|
| Primary | Change in Paretic Limb Step Time (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | seconds | Baseline, 3 months |
|
|
|
| Primary | Change in Paretic Limb Step Time (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | seconds | Baseline, 3 Months |
|
|
|
| Primary | Change in Non-Paretic Limb Step Time (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | seconds | Baseline, 3 months |
|
|
|
| Primary | Change in Non-Paretic Limb Step Time (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | seconds | Baseline, 3 Months |
|
|
|
| Primary | Change in Paretic Limb Step Length (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | cm | Baseline, 3 Months |
|
|
|
| Primary | Change in Paretic Limb Step Length (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | cm | Baseline, 3 months |
|
|
|
| Primary | Change in Non-Paretic Limb Step Length (Self-Selected) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | cm | Baseline, 3 Months |
|
|
|
| Primary | Change in Non-Paretic Limb Step Length (Fastest) | This and other measures come from Instrumented Walkway (Gait Rite) | All participants for whom measurement was recorded at Baseline and 3 months | Posted | Mean | Standard Error | cm | Baseline, 3 Months |
|
|
|
| 2 |
| 22 |
| 3 |
| 22 |
| EG001 | 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 | 2 | 16 | 9 | 16 |
| hypotensive episode | General disorders | following a training session. Further evaluation indicated the need for hospital admission. |
|
| choked on a pill at home | General disorders | went to the ER where he was held overnight |
|
| falls outside of training/ testing sessions | General disorders | none requiring hospitalization |
|
| muscle strain | General disorders | not requiring hospitalization |
|
| gout flare-up | General disorders | no hospitalization but treated by PCP |
|
| adverse reaction to lidocaine during muscle biopsy | General disorders | symptoms resolved after 40 minutes |
|
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |