Contact information
Type
Scientific
Primary contact
Mrs Liv Haehre
ORCID ID
Contact details
Martina Hansens Hospital
Pb. 23
1306 Bærum postterminal
Sandvika
1306
Norway
-
liv.haehre@mhh.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of exercises for persons with Hand OsteoArthritis: a randomised controlled trial
Acronym
HOAexercises
Study hypothesis
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
Ethical Committee for Medical Research, 18/11/2010. ref: 2010/2693a
Study design
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
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
Phase
Drug names
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 trial start date
01/02/2011
Overall trial end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant 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
Recruitment start date
01/02/2011
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Norway
Trial participating centre
Martina Hansens Hospital
Sandvika
1306
Norway
Sponsor information
Organisation
Martina Hansens Hospital (Norway)
Sponsor details
c/o Arne Ekeland
Pb. 23
1306 Bærum postterminal
Sansvika
1306
Norway
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Martina Hansens Hospital (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Norwegian Association of Occupational Therapists (Norsk Ergoterapeutforbund [NETF]) (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24667900