NCT01245842

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

2.4 years

First QC Date

November 19, 2010

Last Update Submit

October 27, 2013

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • The functional index for hand osteoarthritis (FIHOA)

    6 months

  • Patient specific function scale (PSFS)

    6 months

Secondary Outcomes (12)

  • Hand joint pain (Numeric rating scale, 0-10)

    6 months

  • Hand joint stiffness (Numeric rating scale, 0-10)

    6 months

  • Fatigue (numeric rating scale, 0-10)

    6 months

  • Patient global assessment of disease activity (Numeric rating scale, 0-10)

    6 months

  • Exercise self-efficacy

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

Exercise group

EXPERIMENTAL
Other: Hand exercise program

Interventions

Hand exercise programOTHER

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.

Exercise group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The American College of Rheumatology (ACR) classification criteria for clinical hand osteoarthritis
  • FIHOA ≥ 5 at pre-baseline
  • The persons must have a telephone

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy and Occupational Therapy Service Centre

Ullensaker Municipality, Jessheim, 2050, Norway

Location

Related Publications (2)

  • 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.

    PMID: 25008206DERIVED

  • 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.

    PMID: 24629063DERIVED

Study Officials

  • Nina Østerås, PT, PhD

    Diakonhjemmet Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 23, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

NO(1)