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

NCT ID: NCT02140866

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Hand Exercise

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

Group Type EXPERIMENTAL

Hand Exercise

Intervention Type OTHER

Compensatory Intervention Program (CIP)

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

Group Type ACTIVE_COMPARATOR

Compensatory Intervention Program (CIP)

Intervention Type OTHER

Interventions

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Hand Exercise

Intervention Type OTHER

Compensatory Intervention Program (CIP)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oak Foundation

OTHER

Sponsor Role collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role collaborator

Danish Physiotherapy Foundation

UNKNOWN

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Danish Association of Occupational Therapist

OTHER

Sponsor Role collaborator

Parker Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Eva Ejlersen Wæhrens

Senior researcher, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva E Wæhrens, PhD

Role: PRINCIPAL_INVESTIGATOR

The Parker Research Institute

Locations

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Copenhagen University Hospital, Frederiksberg

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31242937 (View on PubMed)

Other Identifiers

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109

Identifier Type: -

Identifier Source: org_study_id