Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Self Efficacy :COPD Self Efficacy Scale (CSES)
研究概览
简要总结
The purpose of this study was to compare the self-efficacy and quality of life parameters of Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation with and without Tai Chi elements incorporated in the exercise component in a General Out-patient setting.
详细描述
Subjects: 192 patients were enrolled and recruited from four General Out-patient clinics in Yau Tsim Mong and Wong Tai Sin districts.
Study Design: Prospective single blind randomized controlled trial
Subjects were randomized into Pulmonary rehabilitation program (PRP) group (n = 98) and Pulmonary rehabilitation program with Tai chi group (TC)(n=94). Details of PRP and PRP + Tai Chi will be discussed below.
Both groups will be given booklet on COPD information and management.
Randomization:
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)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Previous diagnosis of COPD
- •. Absence of bronchiectasis, bronchiolitis obliterans, panbronchiolitis and asthma
- •. Medical Research Council(MRC)Dyspnea score > 2 using the 1-5 scale version
- •.Willing to participate and able to give consent
排除标准
- •. Patients with poor mobility, i.e. wheelchair bound; or
- •. Patients with severe comorbidities, including acute myocardial infarction in preceding 6 months; or
- •. Patients with severe hearing impairment or cognitive impairment; or
- •. Patient unwilling to participate and unable to give consent
结局指标
主要结局
Self Efficacy :COPD Self Efficacy Scale (CSES)
时间窗: Change in CSES at 6 months post-intervention
34 item questionnaire consisting of likert scale with 5 responses ranging from "1" indicating " not at all confident" to "5" indicating " very confident" with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as "not at all confident and 1 as "very confident". The validated Chinese version of CSES was also used
Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)
时间窗: Change in SEMSOB at 6 months post-intervention
The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients' overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.
SGRQ HKC-Symptoms
时间窗: 6 months post-intervention
SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC-Activity
时间窗: 6 months post-intervention
SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC-Impact
时间窗: 6 months post-intervention
SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC Total
时间窗: 6 months post-intervention
SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
次要结局
- FEV1(6 months post-intervention)
- FEV1% Pred(6 months post-intervention)
- 6 MWT in Meters(6 months post-intervention)
- FVC(6 months post intervention)
研究者
Lorna Ventura Ng
Senior Medical Officer
Kwong Wah Hospital