- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01245842
The Hand Osteoarthritis Exercise Trial
Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jessheim
-
Ullensaker Municipality, Jessheim, Norway, 2050
- Physiotherapy and Occupational Therapy Service Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Usual care
|
|
|
EXPERIMENTAL: Exercise group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The functional index for hand osteoarthritis (FIHOA)
Time Frame: 6 months
|
6 months
|
|
Patient specific function scale (PSFS)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hand joint pain (Numeric rating scale, 0-10)
Time Frame: 6 months
|
6 months
|
|
Hand joint stiffness (Numeric rating scale, 0-10)
Time Frame: 6 months
|
6 months
|
|
Fatigue (numeric rating scale, 0-10)
Time Frame: 6 months
|
6 months
|
|
Patient global assessment of disease activity (Numeric rating scale, 0-10)
Time Frame: 6 months
|
6 months
|
|
Exercise self-efficacy
Time Frame: 6 months
|
6 months
|
|
Health related quality of life (15D)
Time Frame: 6 months
|
6 months
|
|
Self-reported work ability and sick leave
Time Frame: 6 months
|
6 months
|
|
Self-reported health care utilisation
Time Frame: 6 months
|
6 months
|
|
Grip strength (JAMAR)
Time Frame: 6 months
|
6 months
|
|
Grip size
Time Frame: 6 months
|
6 months
|
|
Hand functioning (The Moberg Pick Up Test)
Time Frame: 6 months
|
6 months
|
|
Global assessment of change of hand problem
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina Østerås, PT, PhD, Diakonhjemmet Hospital
Publications and helpful links
General 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.
- Osteras 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100286_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hand Osteoarthritis
-
Mayo ClinicRecruitingOsteoarthritis Wrist | Osteoarthritis HandUnited States
-
Sint MaartenskliniekZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingHand OsteoarthritisNetherlands
-
Centre Hospitalier Universitaire de NiceNot yet recruitingErosive Hand OsteoarthritisFrance
-
University of ZurichWithdrawnHand Osteoarthritis | Wrist Injuries | Wrist Fracture | Hand Injury Wrist | Wrist Arthritis | Hand Fracture | Hand Sprain
-
TC Erciyes UniversityEnrolling by invitationHand Osteoarthritis | Thumb OsteoarthritisTurkey (Türkiye)
-
FoU Center SpenshultThe Swedish Rheumatism AssActive, not recruitingOsteoarthritis, Knee | Osteoarthritis Hand | Osteoarthritis GeneralizedSweden
-
Diakonhjemmet HospitalEnrolling by invitationHand Osteoarthritis | Erosive OsteoarthritisNorway
-
Henning BliddalCompletedOsteoarthritis Hand | Osteoarthritis FingerDenmark
-
Vita CareTegos S.A.CompletedOsteoarthritis | Osteoarthritis Hand | Osteoarthritis Finger | Osteoarthritis Both HandsBrazil
-
Diakonhjemmet HospitalOslo University HospitalActive, not recruitingHand Osteoarthritis | Erosive OsteoarthritisNorway
Clinical Trials on Hand exercise program
-
University of ManitobaCanadian Arthritis NetworkCompletedRheumatoid Arthritis | Osteoarthritis of HandsCanada
-
University of California, IrvineCompletedSpinal Cord InjuriesUnited States
-
David ReinkensmeyerCompletedCerebrovascular AccidentUnited States
-
Parker Research InstituteOak Foundation; The Danish Rheumatism Association; Aase and Ejnar Danielsens... and other collaboratorsCompletedRheumatoid ArthritisDenmark
-
Istanbul University - CerrahpasaCompletedHand Function in Desk-Based WorkersTurkey (Türkiye)
-
The Hong Kong Polytechnic UniversityCompleted
-
University of California, IrvineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Riphah International UniversityRecruitingAthletic Performance and Injury RiskPakistan
-
Ahmed AlshimyCompleted
-
The Arthritis Research Institute of AmericaCompletedOsteoarthritisUnited States