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

NCT05975229 | Completed

• 1 other identifier: H02-16-12
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis

Keywords

hand; osteoarthritis; exercise; knitting; women; pain; stiffness

Outcome Measures

Primary Outcomes (1)

• Stiffness

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

  daily for 12 weeks

Secondary Outcomes (9)

• Dropout rates

  week 8

• Adherence to the knitting program

  Baseline, week 4, week 8, and week 12

• pain level

  Multiple times daily for 12 weeks

• Functional status

  Baseline, week 4, week 8, and week 12

• Hand physical activity

  Baseline, week 4, week 8, and week 12

Study Arms (2)

experimental

EXPERIMENTAL

Educational pamphlet and knitting program

Other: Knitting and education (pamphlet)

control

OTHER

Educational pamphlet and assigned to a waiting list

Other: Education (pamphlet)

Interventions

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.

experimental

Education (pamphlet) OTHER

Receive only the pamphlet, not the knitting program.

control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• University of Ottawa: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Quebec, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity; Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blind, two-arm pilot RCT with a parallel group design

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CA (1)