Clinical trial NCT05975229: The Effects of a Knitting Program on Osteoarthritis Symptoms in Elderly Women
Official title: The Effects of an 8-week Knitting Program on Osteoarthritis Symptoms in Elderly Women: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: hand
osteoarthritis
exercise
knitting
women
pain
stiffness
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2023-08-03
Enrollment: 37
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, two-arm pilot RCT with a parallel group design
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Stiffness
timeFrame: daily for 12 weeks
Secondary outcomes:
measure: Dropout rates
timeFrame: week 8
measure: Adherence to the knitting program
timeFrame: Baseline, week 4, week 8, and week 12
measure: pain level
timeFrame: Multiple times daily for 12 weeks
measure: Functional status
timeFrame: Baseline, week 4, week 8, and week 12
measure: Hand physical activity
timeFrame: Baseline, week 4, week 8, and week 12
measure: Patient's global impression of change
timeFrame: Baseline, week 4, week 8, and week 12
measure: Health-related Quality of life (QoL)
timeFrame: Baseline, week 4, week 8, and week 12
measure: Self-efficacy
timeFrame: Baseline, week 4, week 8, and week 12
measure: Bilateral hand grip strength
timeFrame: Baseline, week 4, week 8, and week 12
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Quebec
Study officials:
References: