StrokeNCT00827827
Strength Training for Skeletal Muscle Adaptation After Stroke
A study testing Exercise- Strength Training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise- Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 6 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Exercise- Strength Training, Exercise- Stretching Control
- Keywords
- Stroke, Exercise, Strength Training, Skeletal Muscle, Insulin Sensitivity
- Medical subject headings
- Stroke, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise- Strength TrainingOther
3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.
Exercise- Stretching ControlOther
3x per week upper and lower body stretching mixed with active and passive range of motion exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise- Strength Training |
| 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. Receives: Other: Exercise- Stretching Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)
Measured: Baseline, 3 months
Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)
Measured: Baseline, 3 months
Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)
Measured: Baseline, 3 Months
Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)
Measured: 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).
Measured: 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).
Measured: Baseline, 3 months
Change in 6-minute Walk Distance
Measured: Baseline, 3 Months
Change in 10 Meter Walking Speed (Self-Selected)
Measured: Baseline, 3 months
Change in 10 Meter Walking Speed (Fastest)
Measured: Baseline, 3 Months
Change in Peak Aerobic Capacity (VO2 Peak)
Measured: 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.
Measured: Baseline, 3 months
Change in Paretic Limb Step Time (Self-Selected)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 months
Change in Paretic Limb Step Time (Fastest)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 Months
Change in Non-Paretic Limb Step Time (Self-Selected)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 months
Change in Non-Paretic Limb Step Time (Fastest)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 Months
Change in Paretic Limb Step Length (Self-Selected)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 Months
Change in Paretic Limb Step Length (Fastest)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 months
Change in Non-Paretic Limb Step Length (Self-Selected)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 Months
Change in Non-Paretic Limb Step Length (Fastest)
This and other measures come from Instrumented Walkway (Gait Rite)
Measured: Baseline, 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study start1 Apr 2009
- Primary completion31 Aug 2013
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Frederick M Ivey, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827827
- Sponsor's protocol ID
- B6737-R
- Other IDs
- H30631
- Status last verified
- Jun 2018
- First submitted
- 22 Jan 2009
- Last updated
- 9 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27865696Ivey 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.
PubMed 23352685
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training for Skeletal Muscle Adaptation After Stroke
- ClinicalTrials.gov ID
- NCT00827827
- Acronym / sponsor ID
- B6737-R
- Conditions
- Stroke
- Keywords
- Stroke, Exercise, Strength Training, Skeletal Muscle, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Exercise- Strength TrainingParticipants 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 | Other: Exercise- Stretching ControlParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise- Strength Training3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour. | Other | Arm 1 |
| Exercise- Stretching Control3x per week upper and lower body stretching mixed with active and passive range of motion exercises | Other | Arm 2 |
Primary outcome
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)
Time frame: Baseline, 3 months
Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)
Time frame: Baseline, 3 months
Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)
Time frame: Baseline, 3 Months
Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)
Time frame: Baseline, 3 Months
Change in Leg Muscle Endurance (Paretic Side)
Time frame: Baseline, 3 Months
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).
Change in Leg Muscle Endurance (Non-Paretic Side)
Time frame: Baseline, 3 months
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).
Change in 6-minute Walk Distance
Time frame: Baseline, 3 Months
Change in 10 Meter Walking Speed (Self-Selected)
Time frame: Baseline, 3 months
Change in 10 Meter Walking Speed (Fastest)
Time frame: Baseline, 3 Months
Change in Peak Aerobic Capacity (VO2 Peak)
Time frame: Baseline, 3 Months
Change in Berg Balance Scale
Time frame: Baseline, 3 months
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.
Change in Paretic Limb Step Time (Self-Selected)
Time frame: Baseline, 3 months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Paretic Limb Step Time (Fastest)
Time frame: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Non-Paretic Limb Step Time (Self-Selected)
Time frame: Baseline, 3 months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Non-Paretic Limb Step Time (Fastest)
Time frame: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Paretic Limb Step Length (Self-Selected)
Time frame: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Paretic Limb Step Length (Fastest)
Time frame: Baseline, 3 months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Non-Paretic Limb Step Length (Self-Selected)
Time frame: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Change in Non-Paretic Limb Step Length (Fastest)
Time frame: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27865696Ivey 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.
- Results publication: PubMed 23352685Ivey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick M Ivey, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise- Strength Training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side) (time frame: Baseline, 3 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.