Clinical trial NCT02140866: Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial
Official title: Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
Collaborators: name: Oak Foundation
name: Aase and Ejnar Danielsens Foundation
name: Danish Physiotherapy Foundation
name: The Danish Rheumatism Association
name: Danish Association of Occupational Therapist
First posted: 2014-05-16
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
timeFrame: within 2 weeks post intervention
Secondary outcomes:
measure: The Assessment of Motor and Process Skills(AMPS) - the process skill scale
timeFrame: within 2 weeks post intervention
measure: The Activities of Daily Living Questionnaire (ADL-Q)
timeFrame: within 2 weeks post intervention
measure: Health Assessment Questionnaire (HAQ)
timeFrame: within 2 weeks post intervention
measure: Overall disease activity (DAS-28)
timeFrame: within 2 weeks post intervention
measure: Grip strength
timeFrame: within 2 weeks post intervention
Other outcomes:
measure: Ultrasound Doppler
timeFrame: within 2 weeks post intervention
Locations:
city: Frederiksberg
country: Denmark
facility: Copenhagen University Hospital, Frederiksberg
Study officials:
affiliation: The Parker Research Institute
name: Eva E Wæhrens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.