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Trial registered on ANZCTR


Registration number
ACTRN12617000843358
Ethics application status
Approved
Date submitted
13/05/2017
Date registered
7/06/2017
Date last updated
4/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The knitting community-based trial for older women with osteoarthritis of the hands: design and rationale of a randomized controlled trial
Scientific title
Effect of community-based knitting on morning stiffness in older women with osteoarthritis of the hands: Design and rationale
Secondary ID [1] 291902 0
Nil Known
Universal Trial Number (UTN)
U1111-1196-4260
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand osteoarthritis 303205 0
Condition category
Condition code
Musculoskeletal 302638 302638 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in both groups will continue with their ongoing medical care to measure the true effect of the knitting intervention, active hand exercises need to be avoided
since they are proven effective for hand osteoarthritis. This may not be possible thus all participants will complete a daily activity log. Participants in Group 1 will take part in a low-intensity knitting program, performed as a morning functional activity, which will comprise two components: 1) bi-weekly 20-min knitting sessions at a senior’s club and 2) 20-min home daily knitting sessions for the five remaining weekdays over 12 consecutive weeks (total of 90 sessions). The bi-weekly 20-min knitting session will take place, at a Senior’s Club in metropolitan Ottawa, on Tuesday and Thursday mornings with a group of regular members who knit wool blankets for sick children admitted CHEO, a regional Children’s Hospital. The blankets are composed of individual squares that are assembled together. Each wool square takes approximately 20 min for a beginner knitter. Each knitter will be encouraged to knit one wool square per day for a total of seven squares per week. To avoid excessive isometric strength and potential muscle fatigue with the use of small needles that require precise pinching, participants will use specific knitting needle and wool sizes
(sizes #6 and #5 respectively according to the Standard Yarn Weight System (http://www.craftyarncouncil.com/weight.html). Study participants will learn how to knit
with a qualified instructor from Senior’s Club during the knitting sessions which will also be supervised by a trained occupational therapist to ensure that the physiological and clinical characteristics of therapeutic exercise are being met. A knitting instructor will ensure that participants follow the prescribed program and if their individual logbooks, where they recorded their daily hand activities and morning stiffness and pain levels, are filled properly. In the event that a session is missed, participants in Group 1 will receive a telephone reminder from the research assistant to encourage them to attend the next session. At the end of 12 weeks, participants will be encouraged to continue on with the program if they gained an improvement of their condition.
Intervention code [1] 298023 0
Rehabilitation
Intervention code [2] 298024 0
Behaviour
Intervention code [3] 298200 0
Treatment: Other
Comparator / control treatment
Participants assigned to the control group (Group 2) will be placed on a waiting list until the end of the study (12 weeks) plus the 4-week follow-up period. The research coordinator will offer one introductory session to explain how to record activity in their logbooks as well a weekly telephone follow-up by the coordinator inquire whether the participant has any questions using their logbooks. They will not be permitted to attend knitting sessions at the senior’s club during the study duration. After the completion of the study duration, the knitting sessions will be available to all study participants. To avoid potential contamination, individuals in Group 2 will have no contact with the individuals registered at The Pace Setters Senior’s Club in Group 1. Club membership annual fees ($10/year) will be paid for all study participants in Group 1 and for those in Group 2 only after the completion of the study. Free knitting material and lessons will be provided for all study participants.
Control group
Active

Outcomes
Primary outcome [1] 302053 0
Morning stiffness (intensity) will be measured using the daily visual analogue scale
Timepoint [1] 302053 0
Outcome will be recorded before (baseline) and after knitting (immediately, 2 hours and four hours after the 20-minute knitting daily morning activity), at 3, 6, 9 and 12 weeks as well as 4 weeks follow-up. Daily morning stiffness after 2 hours knitting daily morning activity will be the primary outcome measure of this protocol.
Primary outcome [2] 302271 0
Morning stiffness (duration) will be measured using the daily visual analogue scale
Timepoint [2] 302271 0
Outcome will be recorded before (baseline) and after knitting (immediately, 2 hours and four hours after the 20-minute knitting daily morning activity), at 3, 6, 9 and 12 weeks as well as 4 weeks follow-up. Daily morning stiffness after 2 hours knitting daily morning activity will be the primary outcome measure of this protocol.
Secondary outcome [1] 334625 0
Pain relief (intensity) will be measured using the daily visual analogue scale
Timepoint [1] 334625 0
Outcome will be recorded before (baseline) and after knitting (immediately, 2 hours and four hours after the 20-minute knitting daily morning activity), at 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [2] 334626 0
Functional status will be measured using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) tool. The AUSCAN includes a 15-item scale, with items grouped into three sub-sections: A) pain intensity, B) stiffness severity and C) hand functional status/difficulty in activities of daily living. It uses a five-point scoring system. It uses a five-point scoring system. A score of 0 represents no pain or no severity in
stiffness or no difficulty in performing functional tasks; scores between one and four represent mild to extreme gradations, respectively. Morning stiffness and hand functional status are included in the AUSCAN.
Timepoint [2] 334626 0
Outcome will be recorded at baseline, 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [3] 334627 0
Hand activity level will be measured using the 7-Day Physical Activity Readiness tool was considered to indicate the duration (minutes per day) and frequency (days per week) of the activity. An adapted version will be included in the logbooks where physical activity is split into distinct Knitting and other hand activities categories. The logbooks will also include a daily visual analogue scale for morning stiffness and pain intensity before and after knitting, information about hand activity level and knitting technique as well as a weekly questionnaire on actual changes in physical activity, medication intake (not encouraged), habits and adverse events. Patient global assessment will be evaluated by asking patients if their condition after knitting program “fully improved”, “partially improved”, “did not improve” or “was worse compared to the beginning of the study”. A similar logbook was created for PA activity other than knitting recording for the participants in the control group 2.
Timepoint [3] 334627 0
Outcome will be recorded at baseline, 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [4] 334628 0
Health-related quality of life will be assessed using the EuroQoL Index (EQ-5D-5L) including mobility, self-care, usual activities, pain/discomfort and anxiety/depression subscales.
Timepoint [4] 334628 0
Outcome will be recorded at baseline, 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [5] 334629 0
The disease activity status will be measured by the presence of finger inflammation of active joints using a standardized physical assessment (http://arthritis.scholarlab.com/jointinflammation/) featured by The Arthritis Society and performed by a therapist from The Arthritis Society. Two physical assessments will also be performed: 1) The Functional Index for Hand Osteoarthritis (FIHOA) will be used as a performance-based physical function measure as well as 2) dynamometric strength measurements for hand/fingers.
Timepoint [5] 334629 0
Outcome will be recorded at baseline, 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [6] 334630 0
Self-efficacy will be assessed using The Stanford Arthritis Self-Efficacy Scale (ASES), a ten-point scale ranging from one (very uncertain) to 10 (very certain).
Timepoint [6] 334630 0
Outcome will be recorded at baseline, 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [7] 334631 0
Level of knitting enjoyment will be measured using Physical Activity Enjoyment Scale (PACES) for participants in Group 1 only
Timepoint [7] 334631 0
Outcome will be recorded at 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.
Secondary outcome [8] 334632 0
Adherence to the knitting program will be estimated as the number of knitting sessions attended at the Club and performed at home divided by the number of knitting sessions prescribed (84 sessions), as recorded in the participants’ logbooks, using the 7-Day Physical Activity Readiness calendar as well as attendance at the senior’s club. (Daily secondary outcome). The number of wool squares that were knitted will be also reported in the participants’ logbooks. However, knitting technique will be recorded how the participants hold the stabilizing and mobile needle and which hand is used by the trained occupational therapist.
Timepoint [8] 334632 0
Outcome will be recorded at baseline, 3, 6, 9 and 12 weeks as well as 4 weeks follow-up.

Eligibility
Key inclusion criteria
To be eligible for this randomized controlled trial, participants will be required to: 1) meet the American College of Rheumatology clinical and radiographic criteria of definite hand osteoarthritis and of mild to moderate severity status and have experienced pain symptoms for at least three months, 2) be between 50 and 85 years of age, 3) have a level of morning stiffness of at least 4/10 on a visual analogue scale for most days of the prior month at the time of study entry, 4) display X-ray evidence of joint space narrowing of the hands, 5) have no knowledge of knitting (do not know how to knit) or have not knitted in the last 2 months; 6) be available for sessions at the senior’s club twice a week, 7) be able to understand written and verbal English instructions.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they: 1) are current active knitters; 2) are unwilling or unable to adhere to the knitting program for 12 consecutive weeks, 3) have other orthopedic, rheumatologic diseases (i.e. inflammatory arthritis, psoriasis arthritis, gout…), or evidence of chondrocalcinosis, 4) had any prior surgery for the finger joints, 5) have any acute disease, such as uncontrolled diabetes mellitus, untreated hypertension, neurological deficits (motor or sensory) or cognitive deficit and mental health conditions, 6) are taking osteoarthritis medication that is expected to change during the study period, 7) receiving current rehabilitation treatment or any other pain-related treatment besides medication for osteoarthritis, 8) have received corticosteroid injection of finger joints within the last 6 months, 9) plan to move or relocate within six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomly assigned to each group (ratio1:1). Participants of group 2 will have access to the knitting program after the completion of the randomized controlled trial. The research coordinator, who is not involved in data collection, will contact the research study Methods Center data manager. Prior to running the randomization
program, the data manager will document the participant’s initials (first and last) and date of birth (month and year). After running the program, the data manager will document the intervention assignment with the participant information, assign a study identification
(ID) and then inform the research assistant of the assignment and participant ID. This process will help ensure concealment of allocation. After randomization, theparticipant will be informed of their group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomization based on a sequence of computer-generated random numbers (using statistical software SAS macro in SAS 9.3) using a blocking factor (randomly varying between 4 and 6) will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The study is a single blind, two-arm RCT with a parallel group design to compare two study groups: 1) a knitting intervention (Group 1) and 2) a waiting list control group (Group 2). The intervention period will be 12 weeks plus a follow-up at 4 weeks post-intervention to measure the retention effect. Since this RCT involves a physical intervention (i.e. knitting program), the therapist, participants, and research coordinator administering the program will not be blinded. A blinded independent assessor will be trained to assess the participants though performance evaluation and self-reported questionnaires given at baseline, three weeks, six weeks, nine weeks, end of study (12 weeks), and four weeks follow-up to reduce detection bias. With training and standard operating procedures, it is anticipated that any performance bias due to unblinding will be minimized. The study protocol is approved by the University of Ottawa Research Ethics Board (#H02-16-12).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarize the study variables and to assess the distributional assumptions of the statistical techniques used. An intention to treat analysis will be conducted for all the data analyses. A per protocol analysis will be considered as part of the sensitivity analyses. The primary outcome is the area under the curve (AUC) at 2 h for stiffness. That is stiffness at 2 h post-awakening from sleep will be assessed each day for 12 weeks, and the AUC over this 12 week period will then be calculated. Similar AUCs will be calculated for stiffness at 0 h (at awakening), 4 h (postawakening) and evening. Also, similar AUCs for the secondary outcomes pain and function will be calculated. For the primary outcome (AUC at 2 h for stiffness) participants in the knitting group will be compared to participants in the control group using independent Student’s t-test with the pooled or separate variance estimate as appropriate. For the primary and secondary outcomes, the area under the curve (AUC) for stiffness, pain and function will be compared using a 2-way analysis of variance (ANOVA) with the between factor group (knitting vs control) and within factor time (0 h, 2 h, 4 h, evening). Tukey’s honest significance difference (HSD) will be used to make specific pairwise comparisons. The secondary outcomes, AUSCAN overall, AUSCAN pain, AUSCAN stiffness, AUSCAN function, hand and fingers strength and physical function, selfefficacy, hand physical activity level and adherence, global patient improvement as well as quality of life will be compared using a 2-way analysis of variance (ANOVA) with the between factor group (knitting vs control) and
within factor time (baseline, 3 wk., 6 wk., 9 wk., 12 wk. and 4-wk Follow-Up). Again, Tukey’s HSD will be used to make specific pairwise comparisons. As a secondary analysis, additional time assessments to 16 weeks will be included in the above analyses to assess followup. An alpha significance of 0.05 was chosen for all analyses. Mixed models repeated measured will be used to accommodate missing data. No interim efficacy or subgroup
analyses are planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 8891 0
Canada
State/province [1] 8891 0
ontario

Funding & Sponsors
Funding source category [1] 296410 0
University
Name [1] 296410 0
University of Ottawa Research Chair Award for graduate students salary support
Country [1] 296410 0
Canada
Primary sponsor type
University
Name
University of Ottawa Research Chair
Address
Tabaret Hall
550 Cumberland St
Room 246
Ottawa, ON, Canada
K1N 6N5
Ottawa
Canada
K1N 6N5
Country
Canada
Secondary sponsor category [1] 295352 0
None
Name [1] 295352 0
Address [1] 295352 0
Country [1] 295352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297634 0
University of Ottawa Research Ethics Board
Ethics committee address [1] 297634 0
Ethics committee country [1] 297634 0
Canada
Date submitted for ethics approval [1] 297634 0
Approval date [1] 297634 0
11/05/2017
Ethics approval number [1] 297634 0
h02-16-12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2756 2756 0 0
/AnzctrAttachments/372901-H02-16-12 Renewal BROSSEAU_Etal (Apr 2018).pdf (Other)

Contacts
Principal investigator
Name 74662 0
Dr Guillaume Léonard
Address 74662 0
Physiotherapy Programme
School of Rehabilitation Sciences
Faculty of Medicine
University of Sherbrooke
3001, 12th North Avenue
Sherbrooke, Qc Canada J1H 5N5
Country 74662 0
Canada
Phone 74662 0
+1 819 780-2220, ext. 45246
Fax 74662 0
Email 74662 0
guillaume.leonard2@usherbrooke.ca
Contact person for public queries
Name 74663 0
Paulette Guitard
Address 74663 0
Faculty of Health Sciences
School of Rehabilitation Sciences
University of Ottawa
451 Smyth Road
Ottawa, ON Canada
K1H 8M5
Country 74663 0
Canada
Phone 74663 0
+1 (613) 562-5800
Fax 74663 0
Email 74663 0
Guitardp@uottawa.ca
Contact person for scientific queries
Name 74664 0
Paulette Guitard
Address 74664 0
Faculty of Health Sciences
School of Rehabilitation Sciences
University of Ottawa
451 Smyth Road
Ottawa, ON Canada
K1H 8M5
Country 74664 0
Canada
Phone 74664 0
+1 (613) 562-5800
Fax 74664 0
Email 74664 0
Guitardp@uottawa.ca

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe knitting community-based trial for older women with osteoarthritis of the hands: Design and rationale of a randomized controlled trial.2018https://dx.doi.org/10.1186/s12891-018-1965-2
N.B. These documents automatically identified may not have been verified by the study sponsor.