Effect of exercises in Hand OsteoArthritis
| ISRCTN | ISRCTN79019063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79019063 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/01/2011
- Registration date
- 10/03/2011
- Last edited
- 05/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Liv Haehre
Scientific
Scientific
Martina Hansens Hospital
Pb. 23
1306 Bærum postterminal
Sandvika
1306
Norway
| liv.haehre@mhh.no |
Study information
| Study design | 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 | Effect of exercises for persons with Hand OsteoArthritis: a randomised controlled trial |
| Study acronym | HOAexercises |
| Study objectives | Primary question: Are hand exercises delivered by an occupational therapist (OT) more effective in improving activity performance than no exercises (treatment as usual) in people with hand osteoarthritis (OA) secondary care? Secondary question: Does regular hand exercising improve grip-force, joint mobility and hand pain in people with hand OA? |
| Ethics approval(s) | Ethical Committee for Medical Research, 18/11/2010. ref: 2010/2693a |
| Health condition(s) or problem(s) studied | Hand osteoarthritis |
| Intervention | Group 1 - hand exercises: Participants receive information about HOA and a leaflet containing five suggestions for alternative working methods to improve hand function and performance of daily activities. Thereafter, participants are instructed in five hand exercises, aimed at improving or maintaining joint mobility and grip force. They are given a leaflet with descriptions and pictures of the exercises, and instructed to perform the exercises with ten repetitions three times a week for the first two weeks, thereafter 12 repetitions for the next two weeks and if this is well tolerated to increase to fifteen repetitions for the rest of the trial period. They will be contacted by phone several times during the follow up. Group 2 - treatment as usual (i.e., no exercises): Participants' receive information about HOA and a leaflet containing five suggestions for alternative working methods to improve hand function and performance of daily activities. After completion of the study, participants are taught the same exercise program as participants in group 1. |
| Intervention type | Behavioural |
| Primary outcome measure | Function in performance of daily activities, measured by the Patient Specific Functional Scale (PSFS), assessed at baseline and after three months |
| Secondary outcome measures | Current secondary outcome measures as of 11/07/2013: Assessed at baseline and after three months: 1. Function in performance of daily activities, measured by Measure of Activity Performance of the Hand (MAP-Hand) and the Functional Index of the Hand (FIHOA) 2. Hand pain, stiffness, fatigue and disease activity measured on numeric rating scales (NRS) 3. Hand strength, measured with the Grippit 4. Abduction of the thumb, measured with Gripsizer 5. Joint mobility, measured as flextion or opposition (in millimeter) of digits I to V 6. Self-reported hand function (NRS) 7. Number of participants who fulfill the OMERACT-OARSI responder criteria Participants in the exercise group are also asked to keep a diary where they register their exercising and also self-report hand pain immediately following each exercise bout on a NRS. Previous secondary outcome measures: Assessed at baseline and after three months: 1. Function in performance of daily activities, measured by Measure of Activity Performance of the Hand (MAP-Hand) and the Functional Index of the Hand (FIHOA) 2. Hand pain, stiffness, fatigue and disease activity measured on numeric rating scales (NRS) 3. Hand strength, measured with the Grippit 4. Abduction of the thumb, measured with Gripsizer 5. Joint mobility, measured as flextion or opposition (in millimeter) of digits I to V 6. Self-reported hand function (NRS) Participants in the exercise group are also asked to keep a diary where they register their exercising and also self-report hand pain immediately following each exercise bout on a NRS. |
| Overall study start date | 01/02/2011 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Women aged from 18 to 80 years 2. Hand osteoarthritis according to the American College of Rheumatology (ACR) criteria 3 Stable medication last three months 4. Minimum three self-reported activity limitations caused by hand OA 5. Ability to communicate in Norwegian |
| Key exclusion criteria | 1. Cognitive impairment or mental disease 2. Surgery in the hand for the last 6 months or in the follow-up period 3. Impaired hand function due to other diseases 4. Steroid injections within the last 2 weeks |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- Norway
Study participating centre
Martina Hansens Hospital
Sandvika
1306
Norway
1306
Norway
Sponsor information
Martina Hansens Hospital (Norway)
Hospital/treatment centre
Hospital/treatment centre
c/o Arne Ekeland
Pb. 23, 1306 Bærum postterminal
Sansvika
1306
Norway
| Website | http://www.mhh.no/ |
|---|---|
"ROR" |
https://ror.org/00a2gj556 |
Funders
Funder type
Hospital/treatment centre
Martina Hansens Hospital (Norway)
No information available
Norwegian Association of Occupational Therapists (Norsk Ergoterapeutforbund [NETF]) (Norway)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No |
Editorial Notes
05/05/2016: Publication reference added.
