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OpenTrials
Completed

NCT Number: NCT02120846

Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flywheel leg-press resistance exercise

Other

Other names: Yo-Yo Techonlogy

Primary outcomes

  1. 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.

  2. Change from baseline in Functional Performance at 3 months

    Time frame: Baseline, Month 3

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

  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).

Secondary outcomes

  1. Change from baseline in Spasticity at 3 months

    Time frame: Baseline, Month 3

    Modified Ashworth Scale

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Corporacion Parc Tauli

Registry information

Acronym: KAROL

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2014
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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