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

NCT02140866 | Completed

• 1 other identifier: 109
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• The Assessment of Motor and Process Skills (AMPS) - the motor skill scale

  within 2 weeks post intervention

Secondary Outcomes (5)

• 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 Outcomes (1)

• Ultrasound Doppler

  within 2 weeks post intervention

Study Arms (2)

Hand Exercise

EXPERIMENTAL

The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).

Other: Hand Exercise

Compensatory Intervention Program (CIP)

ACTIVE COMPARATOR

The control group will receive the Compensatory Intervention Program (CIP) only.

Other: Compensatory Intervention Program (CIP)

Interventions

Hand Exercise OTHER

Hand Exercise

Compensatory Intervention Program (CIP) OTHER

Compensatory Intervention Program (CIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parker Research Institute: lead
• Oak Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator
• Danish Physiotherapy Foundation: collaborator
• The Danish Rheumatism Association: collaborator
• Danish Association of Occupational Therapist: collaborator

Study Sites (1)

Copenhagen University Hospital, Frederiksberg

Frederiksberg, 2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31242937 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eva E Wæhrens, PhD

  The Parker Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, PhD

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

DK (1)