Condition category
Musculoskeletal Diseases
Date applied
07/01/2011
Date assigned
10/03/2011
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mhh.no/

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24667900

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.