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
研究组 & 干预措施
Tai chi + PRP
Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
干预措施: Tai chi + PRP (Other)
PRP
PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
干预措施: PRP (Other)
Tai chi + PRP
Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
干预措施: PRP (Other)
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
- 6 MWT in Meters(6 months post-intervention)
- FVC(6 months post intervention)
- FEV1(6 months post-intervention)
- FEV1% Pred(6 months post-intervention)
研究者
Lorna Ventura Ng
Senior Medical Officer
Kwong Wah Hospital