Condition category
Circulatory System
Date applied
14/01/2011
Date assigned
05/04/2011
Last edited
11/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 June 2018

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Staffan Eriksson

ORCID ID

Contact details

FoU-centrum Sörmland
Kungsgatan 41
Eskilstuna
SE-631 88
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The use of aerobic exercise to augment training of motor skill in stroke rehabilitation: a randomised controlled trial

Acronym

Study hypothesis

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

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)

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Other

Phase

Drug names

Primary outcome measures

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 trial start date

24/01/2011

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46

Participant 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

Recruitment start date

24/01/2011

Recruitment end date

30/06/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Avesta Lasarett
Geriatriska rehabiliteringsenheten
Avesta
774 82
Sweden

Trial participating centre

Rmonthagen
Öppenvårdsrehab, stroke och hjärnskaderehab Solidenvägen 58
Östersund
831 83
Sweden

Trial participating centre

Sjukhuset i Arvika
Sjukgymnastiken i Arvika Rackstavägen
Arvika
671 80
Sweden

Trial participating centre

Länssjukhuset Ryhov
Rehabmedicin/sjukymnastik Hus T1
Jönköping
551 85
Sweden

Trial participating centre

Norrlands universitetssjukhus
Geriatriska kliniken
Umeå
901 85
Sweden

Trial participating centre

Blekingesjukhuset
Arbetsterapin
Karlskrona
37185
Sweden

Trial participating centre

Paramedicin
Geriatrik/rehab Borlänge sjukhus Box 731
Borlänge
781 27
Sweden

Trial participating centre

Sjukgymnastiken Korpen
Brömsebroväg 8 Box 1254
Visby
621 23
Sweden

Trial participating centre

Vrinnevisjukhuset
Rehab öst Vrinnevi
Norrköping
601 82
Sweden

Trial participating centre

Rörelse och hälsa
Dag/hemrehab Brigadgatan 22
Linköping
587 58
Sweden

Sponsor information

Organisation

Umeå University (Sweden)

Sponsor details

Community Medicine and Rehabilitation
Department of Physiotherapy
Umeå
SE-901 87
Sweden

Sponsor type

University/education

Website

http://www.umu.se/english

Funders

Funder type

Government

Funder name

County Council of Södermanland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Stroke Association (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Insamlingsstiftelsen för Strokeforskning i Norrland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Legitimerade sjukgymnasters riksförbund, Minnesfonden (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norrbacka-Eugeniastiftelsen (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/03/2016: Plain English summary added. On 07/01/2015 the target number of participants was changed from 60 to 46.