Hand OsteoarthritisNCT01245842
The Hand Osteoarthritis Exercise Trial
A study testing Hand exercise program in people with Hand Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate the effect of a hand exercise intervention on function and osteoarthritis symptoms in persons with hand osteoarthritis . Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Hand exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The American College of Rheumatology (ACR) classification criteria for clinical hand osteoarthritis
- FIHOA ≥ 5 at pre-baseline
- The persons must have a telephone
Who cannot join
- Persons with cognitive dysfunction
- Persons who do not understand Norwegian language
- Persons with inflammatory rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis) or cancer
- Persons that have recently experienced severe trauma
- Persons that have recently gone through OA surgery or other major surgery
Trial locations and contacts
1 site in 1 country.
Norway1 site
Physiotherapy and Occupational Therapy Service Centre
Ullensaker Municipality, Jessheim, 2050
About this study
Official title: Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial
The purpose of this study is to evaluate the effect of a hand exercise intervention on function and osteoarthritis symptoms in persons with hand osteoarthritis .
Read the detailed description
Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population. The disease may have large influences on an individual's function, health related quality of life and participation in the society. In recently published clinical guidelines for management, non-pharmacological approaches are considered as core treatments.
Several studies have demonstrated that exercise may reduce pain and improve function in persons with knee OA, and a similar effect is suggested for hip OA. Regarding effect of exercises in hand OA, available research results are limited, and randomised controlled trials (RCT) of good quality are needed.
- Conditions
- Hand Osteoarthritis
- Being tested
- Hand exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand exercise programOther
Hand exercise program three times/week for 12 weeks. In total four group sessions, otherwise home based. Weekly telephone calls from experienced physiotherapist/occupational therapist addressing adjustments of the exercise program and encouragement of program adherence.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Exercise group | Experimental | Not described Receives: Other: Hand exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional index for hand osteoarthritis (FIHOA)
Measured: 6 months
Patient specific function scale (PSFS)
Measured: 6 months
Secondary outcomes (12)
Hand joint pain (Numeric rating scale, 0-10)
Measured: 6 months
Hand joint stiffness (Numeric rating scale, 0-10)
Measured: 6 months
Fatigue (numeric rating scale, 0-10)
Measured: 6 months
Patient global assessment of disease activity (Numeric rating scale, 0-10)
Measured: 6 months
Exercise self-efficacy
Measured: 6 months
Health related quality of life (15D)
Measured: 6 months
Self-reported work ability and sick leave
Measured: 6 months
Self-reported health care utilisation
Measured: 6 months
Grip strength (JAMAR)
Measured: 6 months
Grip size
Measured: 6 months
Hand functioning (The Moberg Pick Up Test)
Measured: 6 months
Global assessment of change of hand problem
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Principal investigator, Nina Osteras, Diakonhjemmet Hospital
- Investigators
- Nina Østerås, PT, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245842
- Sponsor's protocol ID
- 100286_1
- Status last verified
- Oct 2013
- First submitted
- 19 Nov 2010
- Last updated
- 29 Oct 2013
- Results posted
- No
Publications
Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Kjeken I. Limited effects of exercises in people with hand osteoarthritis: results from a randomized controlled trial. Osteoarthritis Cartilage. 2014 Sep;22(9):1224-33. doi: 10.1016/j.joca.2014.06.036. Epub 2014 Jul 5.
PubMed 25008206Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Aas E, Kjeken I. Exercise programme with telephone follow-up for people with hand osteoarthritis - protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2014 Mar 14;15:82. doi: 10.1186/1471-2474-15-82.
PubMed 24629063
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01245842
- Acronym / sponsor ID
- 100286_1
- Conditions
- Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of a hand exercise intervention on function and osteoarthritis symptoms in persons with hand osteoarthritis .
Detailed description
Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population. The disease may have large influences on an individual's function, health related quality of life and participation in the society. In recently published clinical guidelines for management, non-pharmacological approaches are considered as core treatments.
Several studies have demonstrated that exercise may reduce pain and improve function in persons with knee OA, and a similar effect is suggested for hip OA. Regarding effect of exercises in hand OA, available research results are limited, and randomised controlled trials (RCT) of good quality are needed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Exercise group | Experimental | Other: Hand exercise program |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The American College of Rheumatology (ACR) classification criteria for clinical hand osteoarthritis
- FIHOA ≥ 5 at pre-baseline
- The persons must have a telephone
Key exclusion criteria (5 listed)
- Persons with cognitive dysfunction
- Persons who do not understand Norwegian language
- Persons with inflammatory rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis) or cancer
- Persons that have recently experienced severe trauma
- Persons that have recently gone through OA surgery or other major surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand exercise programHand exercise program three times/week for 12 weeks. In total four group sessions, otherwise home based. Weekly telephone calls from experienced physiotherapist/occupational therapist addressing adjustments of the exercise program and encouragement of program adherence. | Other | Exercise group |
Primary outcome
The functional index for hand osteoarthritis (FIHOA)
Time frame: 6 months
Patient specific function scale (PSFS)
Time frame: 6 months
12 secondary outcomes
Hand joint pain (Numeric rating scale, 0-10)
Time frame: 6 months
Hand joint stiffness (Numeric rating scale, 0-10)
Time frame: 6 months
Fatigue (numeric rating scale, 0-10)
Time frame: 6 months
Patient global assessment of disease activity (Numeric rating scale, 0-10)
Time frame: 6 months
Exercise self-efficacy
Time frame: 6 months
Health related quality of life (15D)
Time frame: 6 months
Self-reported work ability and sick leave
Time frame: 6 months
Self-reported health care utilisation
Time frame: 6 months
Grip strength (JAMAR)
Time frame: 6 months
Grip size
Time frame: 6 months
Hand functioning (The Moberg Pick Up Test)
Time frame: 6 months
Global assessment of change of hand problem
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Derived from this study: PubMed 25008206Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Kjeken I. Limited effects of exercises in people with hand osteoarthritis: results from a randomized controlled trial. Osteoarthritis Cartilage. 2014 Sep;22(9):1224-33. doi: 10.1016/j.joca.2014.06.036. Epub 2014 Jul 5.
- Derived from this study: PubMed 24629063Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Aas E, Kjeken I. Exercise programme with telephone follow-up for people with hand osteoarthritis - protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2014 Mar 14;15:82. doi: 10.1186/1471-2474-15-82.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Østerås, PT, PhD principal investigator
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand exercise program in people with Hand Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The functional index for hand osteoarthritis (FIHOA) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01245842, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013; AzTrials last refreshed its copy on 29 Oct 2026.