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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Flywheel leg-press resistance exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Flywheel resistance exercise, Muscle function, Cognitive function

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Parc Tauli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Flywheel leg-press resistance exercise

Control

Arm Description

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.

Daily routines

Outcomes

Primary Outcome Measures

Change from baseline in Cognitive Function at 3 months
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
Up-and-Go, Fast Gait Speed, Berg Balance Scale
Change from baseline in Muscle Function at 3 months
Isometric and dynamic force, and peak power during flywheel leg-press exercise. Quadriceps muscle volume (MRI).

Secondary Outcome Measures

Change from baseline in Spasticity at 3 months
Modified Ashworth Scale

Full Information

First Posted
April 16, 2014
Last Updated
August 7, 2014
Sponsor
Karolinska Institutet
Collaborators
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT02120846
Brief Title
Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
Acronym
KAROL
Official Title
Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Corporacion Parc Tauli

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Flywheel resistance exercise, Muscle function, Cognitive function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flywheel leg-press resistance exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Daily routines
Intervention Type
Other
Intervention Name(s)
Flywheel leg-press resistance exercise
Other Intervention Name(s)
Yo-Yo Techonlogy
Primary Outcome Measure Information:
Title
Change from baseline in Cognitive Function at 3 months
Description
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.
Time Frame
Baseline, Month 3
Title
Change from baseline in Functional Performance at 3 months
Description
Up-and-Go, Fast Gait Speed, Berg Balance Scale
Time Frame
Baseline, Month 3
Title
Change from baseline in Muscle Function at 3 months
Description
Isometric and dynamic force, and peak power during flywheel leg-press exercise. Quadriceps muscle volume (MRI).
Time Frame
Baseline, Month 3
Secondary Outcome Measure Information:
Title
Change from baseline in Spasticity at 3 months
Description
Modified Ashworth Scale
Time Frame
Baseline, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Fernandez-Gonzalo, Ph.D.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27052303
Citation
Fernandez-Gonzalo R, Fernandez-Gonzalo S, Turon M, Prieto C, Tesch PA, Garcia-Carreira Mdel C. Muscle, functional and cognitive adaptations after flywheel resistance training in stroke patients: a pilot randomized controlled trial. J Neuroeng Rehabil. 2016 Apr 6;13:37. doi: 10.1186/s12984-016-0144-7.
Results Reference
derived

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Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients

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