The Effects of a Knitting Program on Osteoarthritis Symptoms in Elderly Women

NCT ID: NCT05975229

Last Updated: 2023-08-03

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-12-20

Brief Summary

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This pilot randomized controlled trial (RCT) studies the adherence and clinical effectiveness of a knitting program in older females suffering from hand osteoarthritis (HOA) to evaluate the acceptability of this intervention and assess the feasibility of a larger-scale RCT.

It is a single-blind, two-arm pilot RCT with a parallel group design with 40 participants (20 control, 20 experimental). Control participants are given an educational pamphlet and assigned to a waiting list. The knitting program (-8-week duration) has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays. Measures include knitting adherence (implementation outcomes) as well as stiffness, pain, functional status, hand physical activity level, patient's global impression of change, health-related quality of life, self-efficacy, and grip strength (clinical outcomes measured throughout the 8-week program and 4 weeks after the intervention).

Detailed Description

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Background: Exercise therapy is effective in reducing symptoms and disability associated with hand osteoarthritis (HOA) but has low adherence. An intervention consisting in a meaningful occupation, such as knitting, may improve adherence to treatment. This pilot randomized controlled trial (RCT) studies the adherence and clinical effectiveness of a knitting program in older females suffering from HOA to evaluate the acceptability of this intervention and assess the feasibility of a larger-scale RCT.

Methods: Single-blind, two-arm pilot RCT with a parallel group design with 40 participants (20 control, 20 experimental). Control participants are given an educational pamphlet and assigned to a waiting list. The knitting program (-8-week duration) has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays. Measures included knitting adherence (implementation outcomes) as well as stiffness, pain, functional status, hand physical activity level, patient's global impression of change, health-related quality of life, self-efficacy, and grip strength (clinical outcomes measured throughout the 8-week program and 4 weeks after the intervention).

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind, two-arm pilot RCT with a parallel group design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.

Study Groups

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experimental

Educational pamphlet and knitting program

Group Type EXPERIMENTAL

Knitting and education (pamphlet)

Intervention Type OTHER

Pamphlet and knitting program (-8-week duration). The knitting program has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays.

control

Educational pamphlet and assigned to a waiting list

Group Type OTHER

Education (pamphlet)

Intervention Type OTHER

Receive only the pamphlet, not the knitting program.

Interventions

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Knitting and education (pamphlet)

Pamphlet and knitting program (-8-week duration). The knitting program has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays.

Intervention Type OTHER

Education (pamphlet)

Receive only the pamphlet, not the knitting program.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meet the clinical and radiographic criteria of definite HOA set out by the American College of Rheumatology (ACR) and have experienced pain symptoms for at least 3 months;
* Be a woman aged between 50 and 85 years; 3) have moderate to severe morning stiffness (defined as a score ≥ 4 on a 10 cm visual analogue scale at the time of study entry;
* Display X-ray evidence of joint space narrowing of the hands;
* Have no previous experience with knitting or have not knitted in the last 6 months;
* Be available for sessions at the senior's club twice weekly;
* Be able to understand written and verbal English instructions.

Exclusion Criteria

* Suffered from other orthopedic or rheumatologic diseases (e.g., inflammatory arthritis), or showed evidence of chondrocalcinosis;
* Had a history of finger joint surgery;
* Suffered from an acute disease, such as uncontrolled diabetes mellitus, untreated hypertension, neurological deficits (motor or sensory), cognitive deficit or mental health conditions;
* Were taking OA medication that was expected to change during the study period;
* Were receiving current rehabilitation treatments or any other pain-related treatment besides medication for OA;
* Had received a corticosteroid injection in a finger joint within the last 6 months;
* Planned to move outside the region within 6 months.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Ottawa

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Guillaume Léonard

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Ottawa

Ottawa, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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H02-16-12

Identifier Type: -

Identifier Source: org_study_id

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