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

Study Overview
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Brief Summary
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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).

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Hand Exercise
* Other: Compensatory Intervention Program (CIP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand Exercise<br>The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP). | Other: Hand Exercise<br> <br> |
| Active Comparator: Compensatory Intervention Program (CIP)<br>The control group will receive the Compensatory Intervention Program (CIP) only. | Other: Compensatory Intervention Program (CIP)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Assessment of Motor and Process Skills (AMPS) - the motor skill scale |  | within 2 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Assessment of Motor and Process Skills(AMPS) - the process skill scale |  | within 2 weeks post intervention | 
| The Activities of Daily Living Questionnaire (ADL-Q) |  | within 2 weeks post intervention | 
| Health Assessment Questionnaire (HAQ) |  | within 2 weeks post intervention | 
| Overall disease activity (DAS-28) |  | within 2 weeks post intervention | 
| Grip strength |  | within 2 weeks post intervention |