Resistive Training Combined With Nutritional Therapy After Stroke

NCT02347995 | Active Not Recruiting DMC

• 2 other identifiers: N1461-RHP-00062067
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke survivors experience severe muscle wasting during the chronic phase of recovery, with implications for strength, function and general health. Although resistive exercise training effectively combats this problem, it is unknown whether sub-optimal protein intake limits the observed gains in skeletal muscle growth. Skeletal muscle adaptations may occur when resistive training (RT) is combined with nutritional therapy in the form of post- exercise protein consumption. This study would be the first to directly compare RT+protein supplementation to RT+placebo (same calories as protein supplement) in those with chronic hemiparesis caused by stroke, providing evidence-based rationale for combination therapy in the clinical care of this population.

Conditions

Stroke

Keywords

Exercise; Protein; Nutrition; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in thigh muscle area

  muscle area in cm2

  Measured at baseline and after the 3 month intervention

Secondary Outcomes (3)

• Change in muscle strength

  Measured at baseline and after the 3 month intervention

• Change in functional mobility (6 min walk distance)

  Measured at baseline and after the 3 month intervention

• Change in myostatin messenger RNA (mRNA) level

  Measured at baseline and after the 3 month intervention

Study Arms (2)

Resistive Training

PLACEBO COMPARATOR

Participants will drink a placebo beverage after each resistance training session.

Other: Placebo

Resistive Training + Protein

EXPERIMENTAL

Participants will drink 30 grams of whey protein after each resistance training session.

Other: Protein

Interventions

Protein OTHER

This training is designed to target the major muscle groups of the leg. Resistance training will be completed through a combination of lower extremity machines and complemented by whole body exercises such as squatting. The lower extremity machines include leg press, leg extension, and leg curl. This group will drink a beverage containing protein after each training session.

Resistive Training + Protein

Placebo OTHER

This training is designed to target the major muscle groups of the leg. Resistance training will be completed through a combination of lower extremity machines and complemented by whole body exercises such as squatting. The lower extremity machines include leg press, leg extension, and leg curl.This group will drink a placebo beverage after each training session.

Resistive Training

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke \> 3 months prior
• Completion of all regular post-stroke physical therapy
• Adequate language and neurocognitive function to participate in testing and training and to provide informed consent
• Able to walk 10 meters without human assistance

You may not qualify if:

• Regular structured resistive exercise (\>2x/week)
• Alcohol consumption \>3oz. liquor, 3 x 4oz. glasses of wine, or 3 x 12oz beers/day, by self report
• Neurological history of: a) dementia by clinical evaluation, b) severe receptive or global aphasia, which confounds testing and training, operationally defined as unable to follow 2 point commands, c) untreated major depression by clinical interview
• Medical History: a) recent hospitalization (less than 3 months prior to study entry) for severe medical disease, b) orthopedic or chronic pain condition restricting exercise, c) pulmonary or renal failure, d) active cancer, e) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 190/100) f) untreated and / or poorly controlled diabetes with fasting blood glucose of greater than 170 and HbA1c greater than 10.0, g) medications: oral steroids, h) currently pregnant
• Cardiac history of: a) unstable angina, b) recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure (NYHA category II-IV); c) hemodynamically significant valvular dysfunction
• Any medical condition that, in the opinion of the Investigator, might interfere with the subject's participation in the study, poses any added risk for the subject, or confounds the assessment of the subject

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Baltimore VA Medical Center: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Ryan AS, Novitskaya M, Treuth AL. Predictive Equations Overestimate Resting Metabolic Rate in Survivors of Chronic Stroke. Arch Phys Med Rehabil. 2022 Jul;103(7):1352-1359. doi: 10.1016/j.apmr.2022.01.155. Epub 2022 Feb 19.

  PMID: 35192798 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Proteins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Alice S. Ryan, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 28, 2015
• Study Start: August 24, 2015
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)