Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Flywheel leg-press resistance exercise

• Registration Number: NCT02120846
• Lead Sponsor: Karolinska Institutet

Brief Summary

Forty patients will be assigned to either a training group (12 wk unilateral knee extension flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients will maintain daily routines and any prescribed rehabilitation program. Established methods to assess muscle and cognitive function will be employed before and after the intervention.

This project will disclose whether an exercise paradigm, known to improve muscle function and increase muscle volume in healthy populations, will induce similar adaptations in chronic stroke patients. More importantly, this study will elucidate if any impairment in cognitive function caused by stroke, can be reversed with this particular resistance exercise regimen.

The information gained from this project will have significant implications and aid in advancing rehabilitation programs and exercise prescriptions for men and women suffering from stroke. The overall objective of this research is to promote independence and hence quality of life in these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-23
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Mild-moderate hemiparetic gait
• > 6 months post-stroke
• Able to perform flywheel leg-press exercise

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Exclusion Criteria

• Unstable angina
• Congestive heart failure
• Severe arterial disease
• Major depression
• Dementia
• Chronic pain
• Psychotic alterations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flywheel leg-press resistance exercise	Flywheel leg-press resistance exercise	Participants from the resistance exercise group will perform a 12-wk unilateral flywheel resistance training program with the paretic limb. Four sets of seven coupled concentric and eccentric actions will be completed in the leg press device using flywheel technology twice weekly. Power in each set and repetition will be measured. During all training sessions, subjects will receive visual real-time feedback of power and force produced during each concentric-eccentric action.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Cognitive Function at 3 months	Baseline, Month 3	Cognitive function will be assessed before and after the training period in all participants. In a 60-90 min session, with 10 min of rest is needed, validated tests will be used to evaluate different domains of cognitive function: Speed of information processing; Short- and long-term memory; Attention; Language; Learning; Delayed recall; Working memory; Inhibition; Visuo-motor scanning; Dual task attention; Quality of life.
Change from baseline in Functional Performance at 3 months	Baseline, Month 3	Up-and-Go, Fast Gait Speed, Berg Balance Scale
Change from baseline in Muscle Function at 3 months	Baseline, Month 3	Isometric and dynamic force, and peak power during flywheel leg-press exercise. Quadriceps muscle volume (MRI).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Spasticity at 3 months	Baseline, Month 3	Modified Ashworth Scale

Trial Locations

Locations (1)

Hospital Universitari Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain