The Effects of an 8-week Knitting Program on Osteoarthritis Symptoms in Elderly Women: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Stiffness
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
experimental
Educational pamphlet and knitting program
干预措施: Knitting and education (pamphlet) (Other)
control
Educational pamphlet and assigned to a waiting list
干预措施: Education (pamphlet) (Other)
结局指标
主要结局
Stiffness
时间窗: daily for 12 weeks
0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness
次要结局
- 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)
- Health-related Quality of life (QoL)(Baseline, week 4, week 8, and week 12)
- Self-efficacy(Baseline, week 4, week 8, and week 12)
- Functional status(Baseline, week 4, week 8, and week 12)
- Patient's global impression of change(Baseline, week 4, week 8, and week 12)
- Bilateral hand grip strength(Baseline, week 4, week 8, and week 12)
- Hand physical activity(Baseline, week 4, week 8, and week 12)
研究者
Guillaume Léonard
Professor
Université de Sherbrooke