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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Hand Exercise; Other: Compensatory Intervention Program (CIP)

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2600
    • Copenhagen University Hospital, Frederiksberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Ultrasound Doppler	within 2 weeks post intervention

Collaborators and Investigators

• Sponsor: Parker Research Institute
• Collaborators: Oak Foundation; The Danish Rheumatism Association; Aase and Ejnar Danielsens Foundation; Danish Physiotherapy Foundation; Danish Association of Occupational Therapist
• Investigators: Principal Investigator: Eva E Wæhrens, PhD, The Parker Research Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 109