Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients

Stroke Clinical Trial

— KAROL  

Official title:

Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120846
• Other study ID #: Flywheel stroke
• Secondary ID: 1301
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: August 7, 2014
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de CatalunyaSpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Flywheel leg-press resistance exercise

Locations

Country	Name	City	State
Spain	Hospital Universitari Parc Tauli	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change from baseline in Functional Performance at 3 months	Up-and-Go, Fast Gait Speed, Berg Balance Scale	Baseline, Month 3	No
Primary	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	No
Secondary	Change from baseline in Spasticity at 3 months	Modified Ashworth Scale	Baseline, Month 3	Yes