Effect of exercises in Hand OsteoArthritis

ISRCTN	ISRCTN79019063
DOI	https://doi.org/10.1186/ISRCTN79019063
Protocol serial number	N/A
Sponsor	Martina Hansens Hospital (Norway)
Funders	Martina Hansens Hospital (Norway), Norwegian Association of Occupational Therapists (Norsk Ergoterapeutforbund [NETF]) (Norway)

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

Martina Hansens Hospital
Pb. 23
1306 Bærum postterminal
Sandvika
1306
Norway

Email	liv.haehre@mhh.no

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Function in performance of daily activities, measured by the Patient Specific Functional Scale (PSFS), assessed at baseline and after three months
Key secondary outcome measure(s)	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.
Completion date	30/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/05/2016: Publication reference added.