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

Study Overview
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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).

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Knitting and education (pamphlet)
* Other: Education (pamphlet)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, two-arm pilot RCT with a parallel group design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>Educational pamphlet and knitting program | Other: Knitting and education (pamphlet)<br>* 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.<br>|
| Other: control<br>Educational pamphlet and assigned to a waiting list | Other: Education (pamphlet)<br>* Receive only the pamphlet, not the knitting program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stiffness | 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 | Assessed through a in-house questionnaire | week 8 | 
| Adherence to the knitting program | 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 | 0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain | Multiple times daily for 12 weeks | 
| Functional status | 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 | 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 | 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) | 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 | 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 | It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position | Baseline, week 4, week 8, and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand, osteoarthritis, exercise, knitting, women, pain, stiffness