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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knitting and education (pamphlet)
Education (pamphlet)
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring hand, osteoarthritis, exercise, knitting, women, pain, stiffness

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of Ottawa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental

control

Arm Description

Educational pamphlet and knitting program

Educational pamphlet and assigned to a waiting list

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dropout rates
Assessed through a in-house questionnaire
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)
pain level
0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain
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)
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.
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
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.
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).
Bilateral hand grip strength
It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position

Full Information

First Posted
July 24, 2023
Last Updated
August 1, 2023
Sponsor
Université de Sherbrooke
Collaborators
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT05975229
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
hand, osteoarthritis, exercise, knitting, women, pain, stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, two-arm pilot RCT with a parallel group design
Masking
Outcomes Assessor
Masking Description
The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
Educational pamphlet and knitting program
Arm Title
control
Arm Type
Other
Arm Description
Educational pamphlet and assigned to a waiting list
Intervention Type
Other
Intervention Name(s)
Knitting and education (pamphlet)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education (pamphlet)
Intervention Description
Receive only the pamphlet, not the knitting program.
Primary Outcome Measure Information:
Title
Stiffness
Description
0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness
Time Frame
daily for 12 weeks
Secondary Outcome Measure Information:
Title
Dropout rates
Description
Assessed through a in-house questionnaire
Time Frame
week 8
Title
Adherence to the knitting program
Description
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)
Time Frame
Baseline, week 4, week 8, and week 12
Title
pain level
Description
0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain
Time Frame
Multiple times daily for 12 weeks
Title
Functional status
Description
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)
Time Frame
Baseline, week 4, week 8, and week 12
Title
Hand physical activity
Description
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.
Time Frame
Baseline, week 4, week 8, and week 12
Title
Patient's global impression of change
Description
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
Time Frame
Baseline, week 4, week 8, and week 12
Title
Health-related Quality of life (QoL)
Description
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.
Time Frame
Baseline, week 4, week 8, and week 12
Title
Self-efficacy
Description
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).
Time Frame
Baseline, week 4, week 8, and week 12
Title
Bilateral hand grip strength
Description
It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position
Time Frame
Baseline, week 4, week 8, and week 12

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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

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