Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients (KAROL)

August 7, 2014 updated by: Rodrigo Fernandez Gonzalo, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Flywheel leg-press resistance exercise
Other Names:
  • Yo-Yo Techonlogy
No Intervention: Control
Daily routines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Cognitive Function at 3 months
Time Frame: 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.
Baseline, Month 3
Change from baseline in Functional Performance at 3 months
Time Frame: Baseline, Month 3
Up-and-Go, Fast Gait Speed, Berg Balance Scale
Baseline, Month 3
Change from baseline in Muscle Function at 3 months
Time Frame: Baseline, Month 3
Isometric and dynamic force, and peak power during flywheel leg-press exercise. Quadriceps muscle volume (MRI).
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Spasticity at 3 months
Time Frame: Baseline, Month 3
Modified Ashworth Scale
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Rodrigo Fernandez-Gonzalo, Ph.D., Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flywheel stroke
  • 1301 (Tesch-Övermo Stiftelsen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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