Power Training Post-stroke

NCT01970592 | Completed Phase 2 Results

• 1 other identifier: O0844-R
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Hemiparesis, strictly defined as (muscular) weakness affecting one side of the body, is seen in three-quarters of individuals following stroke. Weakness in this population results from both neural and muscular factors which include, respectively, the ability to activate skeletal muscle as well as the force generating capacity of the muscle. The overall goal is to improve walking in persons post-stroke by training subjects with an intervention that specifically targets existing neural and muscular impairments, thereby facilitating locomotor recovery.

Conditions

Stroke

Keywords

exercise; rehabilitation; walking

Outcome Measures

Primary Outcomes (1)

• Gait Speed

  The speed the subject chooses to walk when instructed to walk at their "comfortable speed"

  8 weeks

Secondary Outcomes (1)

• Muscle Strength

  8 weeks

Study Arms (1)

POWER

EXPERIMENTAL

Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking.

Behavioral: POWER training

Interventions

POWER training BEHAVIORAL

Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking

Also known as: strength training

POWER

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50-70,
• stroke within the past 6 to 24 months,
• residual paresis in the lower extremity (Fugl-Meyer Lower Extremity motor score \<34),
• ability to walk without assistance and without an ankle foot orthotic (AFO) on the treadmill 30 seconds at speeds ranging from 0.3 - 0.8 m/s, and
• provision of informed consent.
• In addition, all subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study cardiologist.

You may not qualify if:

• Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
• rating on Modified Ashworth Scale 3 at the knee or ankle;
• limited lower extremity range of motion of the knee (passive flexion Range of Motion \[ROM\] \< 90); hip (inability to achieve neutral 0 hip extension); or ankle (inability to achieve 0 of active dorsiflexion);
• history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living (ADLs);
• History of chronic obstructive pulmonary disease (COPD) or oxygen dependence;
• Preexisting neurological disorders, dementia or previous stroke;
• History of major head trauma;
• Legal blindness or severe visual impairment;
• history of significant psychiatric illness
• Life expectancy \<1 yr.,
• Severe arthritis or other problems that limit passive ROM;
• post-stroke depression (PHQ-9 10),
• History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months;
• Uncontrolled diabetes with recent diabetic coma, or frequent insulin reactions;
• Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest;

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

None noted

Results Point of Contact

• Title: Chris Gregory
• Organization: Medical University of South Carolina

gregoryc@musc.edu

8437921078

Study Officials

• Chris M Gregory, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: September 29, 2017
• Study Completion: May 31, 2019
• Last Updated: March 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)