Rheumatoid ArthritisRAHExerciseNCT02140866
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial
A study testing Hand Exercise and Compensatory Intervention Program (CIP) in people with Rheumatoid Arthritis, run by Parker Research Institute at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Hand Exercise and Compensatory Intervention Program (CIP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Frederiksberg
Frederiksberg, 2600
About this study
Official title: 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).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Hand Exercise, Compensatory Intervention Program (CIP)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand ExerciseOther
Compensatory Intervention Program (CIP)Other
| Study group | Role | What they receive |
|---|---|---|
| Hand Exercise | Experimental | The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP). Receives: Other: Hand Exercise |
| Compensatory Intervention Program (CIP) | Active comparator | The control group will receive the Compensatory Intervention Program (CIP) only. Receives: Other: Compensatory Intervention Program (CIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
Measured: within 2 weeks post intervention
Secondary outcomes (5)
The Assessment of Motor and Process Skills(AMPS) - the process skill scale
Measured: within 2 weeks post intervention
The Activities of Daily Living Questionnaire (ADL-Q)
Measured: within 2 weeks post intervention
Health Assessment Questionnaire (HAQ)
Measured: within 2 weeks post intervention
Overall disease activity (DAS-28)
Measured: within 2 weeks post intervention
Grip strength
Measured: within 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oak Foundation, Aase and Ejnar Danielsens Foundation, Danish Physiotherapy Foundation, The Danish Rheumatism Association, Danish Association of Occupational Therapist
- Responsible party
- Principal investigator, Eva Ejlersen Wæhrens, Parker Research Institute
- Investigators
- Eva E Wæhrens, PhD, Principal investigator, The Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140866
- Sponsor's protocol ID
- 109
- Acronym
- RAHExercise
- Status last verified
- Sep 2017
- First submitted
- 2 May 2014
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31242937
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02140866
- Acronym / sponsor ID
- RAHExercise / 109
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Parker Research InstituteUniversity, hospital or other
- Collaborators
- Oak Foundation, Aase and Ejnar Danielsens Foundation, Danish Physiotherapy Foundation, The Danish Rheumatism Association, Danish Association of Occupational Therapist
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Exercise | Experimental | Other: Hand ExerciseThe intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP). |
| Compensatory Intervention Program (CIP) | Active comparator | Other: Compensatory Intervention Program (CIP)The control group will receive the Compensatory Intervention Program (CIP) only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Exercise | Other | Hand Exercise |
| Compensatory Intervention Program (CIP) | Other | Compensatory Intervention Program (CIP) |
Primary outcome
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
Time frame: within 2 weeks post intervention
5 secondary outcomes
The Assessment of Motor and Process Skills(AMPS) - the process skill scale
Time frame: within 2 weeks post intervention
The Activities of Daily Living Questionnaire (ADL-Q)
Time frame: within 2 weeks post intervention
Health Assessment Questionnaire (HAQ)
Time frame: within 2 weeks post intervention
Overall disease activity (DAS-28)
Time frame: within 2 weeks post intervention
Grip strength
Time frame: within 2 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Derived from this study: PubMed 31242937Ellegaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva E Wæhrens, PhD principal investigator
The Parker Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Exercise and Compensatory Intervention Program (CIP) in people with Rheumatoid Arthritis, run by Parker Research Institute at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale (time frame: within 2 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.