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

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT05975229

Collaborator

University of Ottawa (Other)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Other: Knitting and education (pamphlet) Other: Education (pamphlet)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-blind, two-arm pilot RCT with a parallel group designSingle-blind, two-arm pilot RCT with a parallel group design

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Dec 20, 2017

Actual Study Completion Date :

Dec 20, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Stiffness [daily for 12 weeks]
0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness

Secondary Outcome Measures

Dropout rates [week 8]
Assessed through a in-house questionnaire
Adherence to the knitting program [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)
pain level [Multiple times daily for 12 weeks]
0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain
Functional status [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)
Hand physical activity [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.
Patient's global impression of change [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
Health-related Quality of life (QoL) [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.
Self-efficacy [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).
Bilateral hand grip strength [Baseline, week 4, week 8, and week 12]
It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.