NCT02120846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

April 16, 2014

Last Update Submit

August 7, 2014

Conditions

Stroke

Keywords

StrokeFlywheel resistance exerciseMuscle functionCognitive function

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline, Month 3

  • Change from baseline in Functional Performance at 3 months

    Up-and-Go, Fast Gait Speed, Berg Balance Scale

    Baseline, Month 3

  • 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).

    Baseline, Month 3

Secondary Outcomes (1)

  • Change from baseline in Spasticity at 3 months

    Baseline, Month 3

Study Arms (2)

Flywheel leg-press resistance exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

Daily routines

Interventions

Flywheel leg-press resistance exerciseOTHER
Also known as: Yo-Yo Techonlogy
Flywheel leg-press resistance exercise

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27052303DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rodrigo Fernandez-Gonzalo, Ph.D.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 23, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

August 8, 2014

Record last verified: 2014-08

Locations

ES(1)