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OpenTrials
Completed

NCT Number: NCT02140866

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Frederiksberg

Frederiksberg, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Hand Exercise

Other

Compensatory Intervention Program (CIP)

Other

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

Sponsors and collaborators

Lead sponsor

Parker Research Institute

Other

Collaborators

  • Aase and Ejnar Danielsens Foundation
  • Danish Association of Occupational Therapist
  • Danish Physiotherapy Foundation
  • Oak Foundation
  • The Danish Rheumatism Association

Registry information

Official study title

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

Acronym: RAHExercise

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 16, 2014
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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