The Hand Osteoarthritis Exercise Trial
This study is ongoing, but not recruiting participants.
Sponsor:
Diakonhjemmet Hospital
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Nina Osteras, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01245842
First received: November 19, 2010
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
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 .
| Condition | Intervention |
|---|---|
|
Hand Osteoarthritis |
Other: Hand exercise program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) |
| Official Title: | Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Diakonhjemmet Hospital:
Primary Outcome Measures:
- The functional index for hand osteoarthritis (FIHOA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient specific function scale (PSFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hand joint pain (Numeric rating scale, 0-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hand joint stiffness (Numeric rating scale, 0-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Fatigue (numeric rating scale, 0-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient global assessment of disease activity (Numeric rating scale, 0-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Exercise self-efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Health related quality of life (15D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Self-reported work ability and sick leave [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Self-reported health care utilisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Grip strength (JAMAR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Grip size [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hand functioning (The Moberg Pick Up Test) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Global assessment of change of hand problem [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Usual care | |
| Experimental: Exercise group |
Other: Hand exercise program
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.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The American College of Rheumatology (ACR) classification criteria for clinical hand osteoarthritis
- FIHOA ≥ 5 at pre-baseline
- The persons must have a telephone
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245842
Locations
| Norway | |
| Physiotherapy and Occupational Therapy Service Centre | |
| Ullensaker Municipality, Jessheim, Norway, 2050 | |
Sponsors and Collaborators
Diakonhjemmet Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
| Principal Investigator: | Nina Østerås, PT, PhD | Diakonhjemmet Hospital |
More Information
No publications provided
| Responsible Party: | Nina Osteras, Principal Investigator, Diakonhjemmet Hospital |
| ClinicalTrials.gov Identifier: | NCT01245842 History of Changes |
| Other Study ID Numbers: | 100286_1 |
| Study First Received: | November 19, 2010 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Norway: The National Committees for Research Ethics |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013