StrokeKAROLNCT02120846
Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
A study testing Flywheel leg-press resistance exercise in people with Stroke, run by Karolinska Institutet at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Flywheel leg-press resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-moderate hemiparetic gait
- > 6 months post-stroke
- Able to perform flywheel leg-press exercise
Who cannot join
- Unstable angina
- Congestive heart failure
- Severe arterial disease
- Major depression
- Dementia
- Chronic pain
- Psychotic alterations
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke
- Being tested
- Flywheel leg-press resistance exercise
- Keywords
- Stroke, Flywheel resistance exercise, Muscle function, Cognitive function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flywheel leg-press resistance exerciseOther
Also called Yo-Yo Techonlogy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Flywheel leg-press resistance exercise |
| Control | No intervention | Daily routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 3
Change from baseline in Functional Performance at 3 months
Up-and-Go, Fast Gait Speed, Berg Balance Scale
Measured: 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).
Measured: Baseline, Month 3
Secondary outcomes (1)
Change from baseline in Spasticity at 3 months
Modified Ashworth Scale
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Principal investigator, Rodrigo Fernandez Gonzalo, Karolinska Institutet
- Investigators
- Rodrigo Fernandez-Gonzalo, Ph.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120846
- Sponsor's protocol ID
- Flywheel stroke
- Other IDs
- 1301
- Acronym
- KAROL
- Status last verified
- Aug 2014
- First submitted
- 16 Apr 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27052303
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT02120846
- Acronym / sponsor ID
- KAROL / Flywheel stroke
- Conditions
- Stroke
- Keywords
- Stroke, Flywheel resistance exercise, Muscle function, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flywheel leg-press resistance exercise | Experimental | Other: Flywheel leg-press resistance exerciseParticipants 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. |
| Control | No intervention | –Daily routines |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild-moderate hemiparetic gait
- > 6 months post-stroke
- Able to perform flywheel leg-press exercise
Key exclusion criteria (7 listed)
- Unstable angina
- Congestive heart failure
- Severe arterial disease
- Major depression
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flywheel leg-press resistance exerciseAlso: Yo-Yo Techonlogy | Other | Flywheel leg-press resistance exercise |
Primary outcome
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.
Change from baseline in Functional Performance at 3 months
Time frame: Baseline, Month 3
Up-and-Go, Fast Gait Speed, Berg Balance Scale
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).
1 secondary outcome
Change from baseline in Spasticity at 3 months
Time frame: Baseline, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
- Derived from this study: PubMed 27052303Fernandez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Fernandez-Gonzalo, Ph.D. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flywheel leg-press resistance exercise in people with Stroke, run by Karolinska Institutet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Cognitive Function at 3 months (time frame: Baseline, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02120846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.