OsteoarthritisNCT05975229
The Effects of a Knitting Program on Osteoarthritis Symptoms in Elderly Women
A study testing Knitting and education (pamphlet) and Education (pamphlet) in people with Osteoarthritis, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Knitting and education (pamphlet) and Education (pamphlet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an 8-week Knitting Program on Osteoarthritis Symptoms in Elderly Women: A Pilot Randomized Controlled Trial
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).
Read the 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).
- Conditions
- Osteoarthritis
- Being tested
- Knitting and education (pamphlet), Education (pamphlet)
- Keywords
- hand, osteoarthritis, exercise, knitting, women, pain, stiffness
- Medical subject headings
- Osteoarthritis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knitting and education (pamphlet)Other
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)Other
Receive only the pamphlet, not the knitting program.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Educational pamphlet and knitting program Receives: Other: Knitting and education (pamphlet) |
| control | Other | Educational pamphlet and assigned to a waiting list Receives: Other: Education (pamphlet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness
0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness
Measured: daily for 12 weeks
Secondary outcomes (9)
Dropout rates
Assessed through a in-house questionnaire
Measured: 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)
Measured: Baseline, week 4, week 8, and week 12
pain level
0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: Baseline, week 4, week 8, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Aug 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, two-arm pilot RCT with a parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Guillaume Léonard, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975229
- Sponsor's protocol ID
- H02-16-12
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an 8-week Knitting Program on Osteoarthritis Symptoms in Elderly Women: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05975229
- Acronym / sponsor ID
- H02-16-12
- Conditions
- Osteoarthritis
- Keywords
- hand, osteoarthritis, exercise, knitting, women, pain, stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, two-arm pilot RCT with a parallel group design
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Knitting and education (pamphlet)Educational pamphlet and knitting program |
| control | Other | Other: Education (pamphlet)Educational pamphlet and assigned to a waiting list |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | experimental |
| Education (pamphlet)Receive only the pamphlet, not the knitting program. | Other | control |
Primary outcome
Stiffness
Time frame: daily for 12 weeks
0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness
9 secondary outcomes
Dropout rates
Time frame: week 8
Adherence to the knitting program
Time frame: Baseline, week 4, week 8, and week 12
pain level
Time frame: Multiple times daily for 12 weeks
Functional status
Time frame: Baseline, week 4, week 8, and week 12
Hand physical activity
Time frame: Baseline, week 4, week 8, and week 12
Patient's global impression of change
Time frame: Baseline, week 4, week 8, and week 12
Health-related Quality of life (QoL)
Time frame: Baseline, week 4, week 8, and week 12
Self-efficacy
Time frame: Baseline, week 4, week 8, and week 12
Bilateral hand grip strength
Time frame: Baseline, week 4, week 8, and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knitting and education (pamphlet) and Education (pamphlet) in people with Osteoarthritis, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness (time frame: daily for 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.