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

Rheumatoid Arthritis Clinical Trial

— RAHExercise  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140866
• Other study ID #: 109
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: September 19, 2017
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: September 2017
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Hand Exercise

• Compensatory Intervention Program (CIP)

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Frederiksberg	Frederiksberg

Sponsors (6)

Lead Sponsor	Collaborator
Parker Research Institute	Aase and Ejnar Danielsens Foundation, Danish Association of Occupational Therapist, Danish Physiotherapy Foundation, Oak Foundation, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasound Doppler		within 2 weeks post intervention
Primary	The Assessment of Motor and Process Skills (AMPS) - the motor skill scale		within 2 weeks post intervention
Secondary	The Assessment of Motor and Process Skills(AMPS) - the process skill scale		within 2 weeks post intervention
Secondary	The Activities of Daily Living Questionnaire (ADL-Q)		within 2 weeks post intervention
Secondary	Health Assessment Questionnaire (HAQ)		within 2 weeks post intervention
Secondary	Overall disease activity (DAS-28)		within 2 weeks post intervention
Secondary	Grip strength		within 2 weeks post intervention