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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Compensatory Intervention Program (CIP); Other: Hand Exercise

• Registration Number: NCT02140866
• Lead Sponsor: Parker Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compensatory Intervention Program (CIP)	Compensatory Intervention Program (CIP)	The control group will receive the Compensatory Intervention Program (CIP) only.
Hand Exercise	Hand Exercise	The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).

Primary Outcome Measures

Name	Time	Method
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale	within 2 weeks post intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Copenhagen University Hospital, Frederiksberg; 🇩🇰 Frederiksberg, Denmark