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

August 1, 2023 updated by: Guillaume Léonard, Université de Sherbrooke

The Effects of an 8-week Knitting Program on Osteoarthritis Symptoms in Elderly Women: A Pilot Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Ottawa, Quebec, Canada
        • University of Ottawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
Educational pamphlet and knitting program
Other: 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.
Other: control
Educational pamphlet and assigned to a waiting list
Other: Education (pamphlet)
Receive only the pamphlet, not the knitting program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stiffness
Time Frame: daily for 12 weeks
0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness
daily for 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rates
Time Frame: week 8
Assessed through a in-house questionnaire
week 8
Adherence to the knitting program
Time Frame: Baseline, week 4, week 8, and week 12
It was estimated using the logbook and the seniors club attendance sheet, whereby we divided the number of knitting sessions completed (at the club and at home) by the number of knitting sessions prescribed (56 sessions)
Baseline, week 4, week 8, and week 12
pain level
Time Frame: Multiple times daily for 12 weeks
0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain
Multiple times daily for 12 weeks
Functional status
Time Frame: Baseline, week 4, week 8, and week 12
Was assessed using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). It consists in a 15-item scale, with items grouped into three subsections: A) pain intensity, B) stiffness severity, and C) hand functional status/difficulty in activities of daily living. For each item, scores range from 0 (no symptoms) to 4 (severe symptoms)
Baseline, week 4, week 8, and week 12
Hand physical activity
Time Frame: Baseline, week 4, week 8, and week 12
was measured using an adapted version of the 7-Day Physical Activity Readiness (PAR). It is in the form of a calendar in which participants record the duration (minutes per day) and frequency (days per week) of physical activity.
Baseline, week 4, week 8, and week 12
Patient's global impression of change
Time Frame: Baseline, week 4, week 8, and week 12
It was assessed by asking patients if, following the knitting program, their condition was: 1) very much improved; 2) much improved; 3) minimally improved; 4) no change; 5) minimally worse; 6) much worse; 7) very much worse
Baseline, week 4, week 8, and week 12
Health-related Quality of life (QoL)
Time Frame: Baseline, week 4, week 8, and week 12
It was evaluated using the EuroQoL Index (EQ-5D-5L), which covers mobility, self-care, daily activities, Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Baseline, week 4, week 8, and week 12
Self-efficacy
Time Frame: Baseline, week 4, week 8, and week 12
It was assessed using The Stanford Arthritis Self-Efficacy Scale, consisting in statements which patients rate on a ten-point scale ranging from 1 (very uncertain) to 10 (very certain).
Baseline, week 4, week 8, and week 12
Bilateral hand grip strength
Time Frame: Baseline, week 4, week 8, and week 12
It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position
Baseline, week 4, week 8, and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

University of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H02-16-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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