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CompletedNCT02140866RAHExerciseUpdated Sep 20, 2017

Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial

An interventional study of Hand Exercise and Compensatory Intervention Program (CIP) in Rheumatoid Arthritis, sponsored by Parker Research Institute. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-20.

Sponsored by Parker Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The study examines whether hand exercise therapy as an add on to a compensatory intervention program focused on joint protection, assistive devices and alternative methods of doing will improve the performance of ADL tasks requiring hand function in patients with rheumatoid arthritis (RA).

02

Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 55 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Parker Research Institute is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female sex.
  • Age ≥ 18.
  • Diagnosis of rheumatoid arthritis (2).
  • Involvement of the hands, due to minimum one tender wrist, metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint in one of the hands.
  • Be on stable medication for at least 3 months prior to participation.
  • Self-reported decreased ability to perform personal and instrumental ADL tasks involving the hands.

Exclusion criteria

Exclusion Criteria:

  • Significant osteoarthritis of the hand assessed at the initial examination by the rheumatologist
  • Hand surgery within 6 months of study participation
  • Other pain condition involving muscles and/or joints, e.g. fibromyalgia.
  • Prednisolon therapy, change in dose of biological agent or start of treatment with a new biological agent within the last 3 month before study start.
  • Inability to understand the information or to speak Danish
  • Any other condition that in the opinion of the investigator or accessing rheumatologist puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Hand Exercise

    The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).

    Other: Hand Exercise

  • Active comparator
    Compensatory Intervention Program (CIP)

    The control group will receive the Compensatory Intervention Program (CIP) only.

    Other: Compensatory Intervention Program (CIP)

Interventions

  • OtherHand Exercise
  • OtherCompensatory Intervention Program (CIP)
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What researchers measure

Primary outcomes

  1. The Assessment of Motor and Process Skills (AMPS) - the motor skill scale

    Time frame: within 2 weeks post intervention

Secondary outcomes

  1. The Assessment of Motor and Process Skills(AMPS) - the process skill scale

    Time frame: within 2 weeks post intervention

  2. The Activities of Daily Living Questionnaire (ADL-Q)

    Time frame: within 2 weeks post intervention

  3. Health Assessment Questionnaire (HAQ)

    Time frame: within 2 weeks post intervention

  4. Overall disease activity (DAS-28)

    Time frame: within 2 weeks post intervention

  5. Grip strength

    Time frame: within 2 weeks post intervention

Other outcomes

  1. Ultrasound Doppler

    Time frame: within 2 weeks post intervention

07

Study locations

1 site
  • Copenhagen University Hospital, Frederiksberg
    Frederiksberg, 2600, Denmark
08

References and documents

Publications

  • Ellegaard K, von Bulow C, Ropke A, Bartholdy C, Hansen IS, Rifbjerg-Madsen S, Henriksen M, Waehrens EE. Hand exercise for women with rheumatoid arthritis and decreased hand function: an exploratory randomized controlled trial. Arthritis Res Ther. 2019 Jun 26;21(1):158. doi: 10.1186/s13075-019-1924-9. PubMed 31242937 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02140866
Lead sponsor
Parker Research Institute
Collaborators
Oak Foundation, Aase and Ejnar Danielsens Foundation, Danish Physiotherapy Foundation, The Danish Rheumatism Association, Danish Association of Occupational Therapist
Responsible party
Eva Ejlersen Wæhrens (Senior researcher, PhD, Parker Research Institute) — Principal investigator
First posted
May 16, 2014
Start date
May 2014
Primary completion
Mar 2016
Completion
May 2016
Last update
Sep 20, 2017

Study contacts

Eva E Wæhrens, PhD
principal investigator · The Parker Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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