Back to resultsHand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial (RAHExercise)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hand Exercise
Compensatory Intervention Program (CIP)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Copenhagen University Hospital, Frederiksberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hand Exercise
Compensatory Intervention Program (CIP)
Arm Description
The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).
The control group will receive the Compensatory Intervention Program (CIP) only.
Outcomes
Primary Outcome Measures
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
Secondary Outcome Measures
The Assessment of Motor and Process Skills(AMPS) - the process skill scale
The Activities of Daily Living Questionnaire (ADL-Q)
Health Assessment Questionnaire (HAQ)
Overall disease activity (DAS-28)
Grip strength
Full Information
NCT ID
NCT02140866
First Posted
May 2, 2014
Last Updated
September 19, 2017
Sponsor
Parker Research Institute
Collaborators
Oak Foundation, Aase and Ejnar Danielsens Foundation, Danish Physiotherapy Foundation, The Danish Rheumatism Association, Danish Association of Occupational Therapist
1. Study Identification
Unique Protocol Identification Number
NCT02140866
Brief Title
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial
Acronym
RAHExercise
Official Title
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parker Research Institute
Collaborators
Oak Foundation, Aase and Ejnar Danielsens Foundation, Danish Physiotherapy Foundation, The Danish Rheumatism Association, Danish Association of Occupational Therapist
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand Exercise
Arm Type
Experimental
Arm Description
The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).
Arm Title
Compensatory Intervention Program (CIP)
Arm Type
Active Comparator
Arm Description
The control group will receive the Compensatory Intervention Program (CIP) only.
Intervention Type
Other
Intervention Name(s)
Hand Exercise
Intervention Type
Other
Intervention Name(s)
Compensatory Intervention Program (CIP)
Primary Outcome Measure Information:
Title
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
Time Frame
within 2 weeks post intervention
Secondary Outcome Measure Information:
Title
The Assessment of Motor and Process Skills(AMPS) - the process skill scale
Time Frame
within 2 weeks post intervention
Title
The Activities of Daily Living Questionnaire (ADL-Q)
Time Frame
within 2 weeks post intervention
Title
Health Assessment Questionnaire (HAQ)
Time Frame
within 2 weeks post intervention
Title
Overall disease activity (DAS-28)
Time Frame
within 2 weeks post intervention
Title
Grip strength
Time Frame
within 2 weeks post intervention
Other Pre-specified Outcome Measures:
Title
Ultrasound Doppler
Time Frame
within 2 weeks post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva E Wæhrens, PhD
Organizational Affiliation
The Parker Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Frederiksberg
City
Frederiksberg
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31242937
Citation
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.
Results Reference
derived
Learn more about this trial
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial
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