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Completed

NCT Number: NCT05975229

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

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).

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Key information

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa

Ottawa, Quebec, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Knitting and education (pamphlet)

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.

Education (pamphlet)

Other

Receive only the pamphlet, not the knitting program.

Primary outcomes

  1. Stiffness

    Time frame: daily for 12 weeks

    0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness

Secondary outcomes

  1. Dropout rates

    Time frame: week 8

    Assessed through a in-house questionnaire

  2. 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)

  3. pain level

    Time frame: Multiple times daily for 12 weeks

    0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain

  4. 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)

  5. 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.

  6. 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

  7. 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.

  8. 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).

  9. 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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • University of Ottawa

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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