The Hand Osteoarthritis Exercise Trial

October 27, 2013 updated by: Nina Osteras, Diakonhjemmet Hospital

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 .

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jessheim
      • Ullensaker Municipality, Jessheim, Norway, 2050
        • Physiotherapy and Occupational Therapy Service Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nina Østerås, PT, PhD, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (ESTIMATE)

November 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 27, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

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.

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