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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05975229
• Other study ID #: H02-16-12
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: August 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.
• Education (pamphlet)
Receive only the pamphlet, not the knitting program.

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stiffness	0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness	daily for 12 weeks
Secondary	Dropout rates	Assessed through a in-house questionnaire	week 8
Secondary	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
Secondary	pain level	0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain	Multiple times daily for 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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