The MUST Hand Osteoarthritis (OA) Exercise Trial - Full Text View

Sponsor:	Diakonhjemmet Hospital
Collaborator:	Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by:	Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:	NCT01245842

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 From the MUST OA

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Osteoarthritis

U.S. FDA Resources

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 (Grip seizer) [ 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:	January 2013
Estimated Primary Completion Date:	January 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 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The 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

Contacts

Contact: Nina Østerås, PT, PhD	+47 22451500	nina.osteras@medisin.uio.no
Contact: Kåre B. Hagen, PT, Prof.	+47 22451500	k.b.hagen@medisin.uio.no

Locations

Norway
Physiotherapy and Occupational Therapy Service Centre	Recruiting
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 Østerås, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
ClinicalTrials.gov Identifier:	NCT01245842 History of Changes
Other Study ID Numbers:	100286_1
Study First Received:	November 19, 2010
Last Updated:	February 10, 2011
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 February 21, 2012