The use of aerobic exercise to augment training of motor skill in stroke rehabilitation
| ISRCTN | ISRCTN24868616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24868616 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/01/2011
- Registration date
- 05/04/2011
- Last edited
- 06/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
A stroke occurs when the blood supply to part of the brain is cut off. The injury to the brain can lead to weakness or paralysis in one side of the body. The aim of this study is to find out whether a combination of aerobic exercise and motor skill training is better than motor skill training only in the rehabilitation of stroke patients. In this study we will use Constraint Induced Movement Therapy (CIMT) for the motor skill training, which involves rehabilitation of the weaker hand while restraining the stronger hand.
Who can participate?
Patients aged 18 and over who had their first stroke 3 or more months ago.
What does the study involve?
Patients are randomly allocated to either the control group or the intervention group. The control group carry out CIMT for 5 hours and 30 minutes a day over 10 days. The intervention group, in addition to CIMT for about 4 hours and 45 minutes per day, also perform aerobic exercise, consisting of cycling on an exercise bike twice a day for 4 x 5 minutes with 1 minute of rest between. The total duration of training is the same for both groups. Both groups also use a restraint for the stronger hand 90% of the time they are awake to prevent them from using it. Motor skill and hand grip strength are measured at 1 - 7 days before the start of the rehabilitation and 1 day after it has finished.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Umeå University (Sweden)
When is the study starting and how long is it expected to run for?
January 2011 to September 2024
Who is funding the study?
1. County Council of Södermanland (Sweden)
2. National Stroke Association (Sweden)
3. Insamlingsstiftelsen för Strokeforskning i Norrland (Sweden)
4. Legitimerade sjukgymnasters riksförbund, Minnesfonden (Sweden)
5. Norrbacka-Eugeniastiftelsen (Sweden)
Who is the main contact?
Staffan Eriksson
Contact information
Scientific
FoU-centrum Sörmland
Kungsgatan 41
Eskilstuna
SE-631 88
Sweden
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of aerobic exercise to augment training of motor skill in stroke rehabilitation: a randomised controlled trial |
| Study objectives | Our hypothesis is that the effect of a motor skill training program on motor skill performance, in persons with stroke, is enhanced if the training program is complemented with aerobic exercise. |
| Ethics approval(s) | Regional Ethical Review Board in Umeå, reference number (date): 09-104M (09/06/2009), with additional approval 2010/314-32M (27/12/2010), 2011-244-32M (14/07/2011), and 2012-235-32M (05/06/2012) |
| Health condition(s) or problem(s) studied | Stroke rehabilitation |
| Intervention | We wanted to investigate if a combination of aerobic exercise and training of motor skill is better than motor skill training only in rehabilitation of stroke patients. In this study we will use CIMT in stroke patients as a model to test this hypothesis. The ordinary work with CIMT at 10 clinics will be utilized to provide the training of motor skill. In CIMT the training regimen is individualized for each patient. A period of CIMT at these clinics consists of 14 consecutive days, 10 weekdays at the clinic and 2 weekends away from the clinic. During the 10 weekdays the patients carry out CIMT at the clinic and a restraint is used 90% of the time they are awake to prevent them from using the non-paretic hand. During the 2 weekends the patients do not visit the clinic and no CIMT or other training is encouraged apart from that they use a restraint 90% of the time. Patients will consecutively be allocated to either control group or intervention group through randomisation. The control group will during the 10 weekdays carry out CIMT for 5 hours and 30 minutes a day. The intervention group will in addition to CIMT perform aerobic exercise immediately in the morning and after lunch during the 10 weekdays. Aerobic exercise will be conducted as cycling on a stationary bicycle. The intervention group also trains 5 hours and 30 minutes each day which includes cycling and CIMT. Hence, the intervention group will carry out CIMT for about 4 hours and 45 minutes each weekday and also twice a day carry out cycling for 4 x 5 minutes with 1 minute of rest between intervals. The aerobic exercise will be performed prior to the CIMT. They will be cycling at an exertion level corresponding to 13 on the Borg RPE-scale. On weekdays, in both groups, the total duration of training will be 5 hours and 30 minutes and they will also use a restraint for the non-paretic hand 90% of the time they are awake. During the weekends the patients in both groups will submit to the same regimen using a restraint of their non-paretic hand for 90 % of the time when awake. Test procedure: Outcome measures will be tested at 1 - 7 days before start of intervention, i.e. baseline, and at day 1 after intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Motor skill by BL-motor assessment, at baseline and after intervention |
| Secondary outcome measures | 1. Motor skill by Twenty-five Hole Peg Test, at baseline and after intervention 2. Hand grip isometric strength by dynamometer, at baseline and after intervention 3. Cognitive ability by MMSE, at baseline and after intervention 4. Effect of CI-therapy by BL-motor assessment (BLMA), Twenty-five Hole Peg Test (THPT), hand grip isometric strength by dynamomter, at basline and after intervention 5. Effect of CI-therapy, by BLMA and THTPT, with regard to age, sex, motor skill at baseline, time since stroke and whether stroke affects dominant hand 6. The effect of the participants expectation (Likert-type scale) of the effect of CI-therapy on the effect of CI-tharapy by BLMA and THPT, at basline and after intervention 7. If motivated, in a secondary analysis of our primary outcome and secondary outcomes 1-6, we will adjust for clinic and in this analysis we will exclude clinics contributing with less than four participants 8. Concurrent validity of THPT by BLMA and Fugl-Meyer assessment 9. Test-retest reliability of THPT |
| Overall study start date | 24/01/2011 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. An approval from the patient's physician 2. Aged 18 years and over, either sex 3. First time stroke 4. Stroke ≥3 months ago 5. BL-motor assessment score less than or equal to 45 6. Able to pick up and release a tennis ball 3 times in 1 minute 7. Mini-mental state examination (MMSE) score greater than or equal to 24 8. Able to cycle on a stationary bicycle 4 x 5 minutes with 1 minute rest between intervals at an exertion level corresponding to 13 on Borgs RPE-scale |
| Key exclusion criteria | 1. Participants in both groups missing 3 hours or more of training 2. Participants in the intervention group missing more than one session of aerobic exercise, or from two or more interrupted aerobic exercise sessions lacking the same amount of aerobic exercise. 3. Other brain injury than stroke, e.g. intracranial haemorrhage caused by aneurysmal rupture or trauma 4. Neurological disorder such as Parkinson's disease or peripheral nerve damage 5. Stroke affecting brainstem and/or cerebellum 6. Previous participation in constraint-induced movement therapy (CIMT) 7. Current participation in other stroke treatment directed at motor skill 8. Injection of anti-spasticity drugs into upper extremity musculature within the past 3 months |
| Date of first enrolment | 24/01/2011 |
| Date of final enrolment | 12/09/2024 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Avesta
774 82
Sweden
Östersund
831 83
Sweden
Rackstavägen
Arvika
671 80
Sweden
Hus T1
Jönköping
551 85
Sweden
Umeå
901 85
Sweden
Karlskrona
37185
Sweden
Box 731
Borlänge
781 27
Sweden
Box 1254
Visby
621 23
Sweden
Norrköping
601 82
Sweden
Brigadgatan 22
Linköping
587 58
Sweden
Sponsor information
University/education
Community Medicine and Rehabilitation
Department of Physiotherapy
Umeå
SE-901 87
Sweden
| Website | http://www.umu.se/english |
|---|---|
"ROR" |
https://ror.org/05kb8h459 |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
06/06/2025: The following changes were made:
1. The recruitment end date was changed from 30/06/2021 to 12/09/2024.
2. The overall study end date was changed from 30/06/2024 to 30/09/2024.
3. The total final enrollment number was added.
08/08/2023: The following changes have been made:
1. The overall study end date has been changed from 30/06/2023 to 30/06/2024 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/06/2024 to 30/06/2025.
10/08/2022: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2021 to 30/06/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/06/2022 to 30/06/2024.
19/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 30/06/2021.
2. The overall end date was changed from 30/06/2018 to 30/06/2021.
3. The intention to publish date was added.
4. The plain English summary was updated to reflect these changes.
11/03/2016: Plain English summary added.
07/01/2015: the target number of participants was changed from 60 to 46.
