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The Hand Osteoarthritis Exercise Trial

This study has been completed.
Sponsor:
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: October 27, 2013
Last verified: October 2013
  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 ]

Enrollment: 130
Study Start Date: January 2011
Study Completion Date: August 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Diakonhjemmet Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 27, 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 November 27, 2014