Strength Training for Skeletal Muscle Adaptation After Stroke

NCT00827827 | Completed Results DMC

• 2 other identifiers: B6737-RH30631
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Exercise; Strength Training; Skeletal Muscle; Insulin Sensitivity

Outcome Measures

Primary Outcomes (19)

• 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)

  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

Study Arms (2)

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.

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.

Other: Exercise- Stretching Control

Interventions

Exercise- Strength Training OTHER

3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.

Arm 1

Exercise- Stretching Control OTHER

3x per week upper and lower body stretching mixed with active and passive range of motion exercises

Arm 2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 27865696 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.

  PMID: 23352685 RESULT

MeSH Terms

Conditions

Stroke; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Frederick M. Ivey
• Organization: Baltimore VAMC

fivey@grecc.umaryland.edu

410-375-8419

Study Officials

• Frederick M Ivey, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: April 1, 2009
• Primary Completion: August 31, 2013
• Study Completion: June 6, 2018
• Last Updated: July 9, 2018
• Results First Posted: January 19, 2015

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)