此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Physical Activity and Self-Efficacy After Pulmonary Rehabilitation

2014年5月27日 更新者:Noor Diana Binte Mohamed Sani、University College, London

Short Term Effects of Pulmonary Rehabilitation on Level of Physical Activity and Self-Efficacy in Patients With Chronic Obstructive Pulmonary Disease.

The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in patients with chronic obstructive pulmonary disease (COPD).

PR is an evidence-based multidisciplinary approach consisting primarily of a supervised exercise program with educational components. It has demonstrated high efficacy in improving dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in patients with COPD. Despite these improvements, there is no conclusive evidence that these benefits translate to an increase in PA in patient's day-to-day life. This is of concern as low PA is a predictor of all cause mortality, correlated with lower HRQoL, increased level of dyspnoea and higher number of hospital admissions in this group of patients.

Self-efficacy is found to be an instigating force in forming intention to exercise and in maintaining practice for an extended time. Self-efficacy may be the key in determining whether a patient translates the improvement in exercise tolerance to actually being more physically active. Based on current knowledge, there is insufficient evidence that self-efficacy increases after pulmonary rehabilitation and no correlation has been made between level of self-efficacy and level of PA in these group of patients.

Hence this study aims to find out whether the existing PR program increases level of PA and self-efficacy. Correlation between level of PA and self-efficacy will be made.

研究概览

地位

未知

详细说明

The intervention group will consist of all patients with chronic obstructive pulmonary disease (COPD) referred to Guy's and St Thomas' Hospital (GSTT) pulmonary rehabilitation. A sample of 30 is anticipated as this is the maximum number of patients who could be enrolled in the 3 month recruitment period in Guy's and St. Thomas' Hospital.

  1. The patient information sheet, together with the referral for PR, will be posted to the patients. Patients will be informed about the study details in the patient information sheet. This will include the fact that they have to wear an accelerometer for 5 to 7 days prior to starting the program. These accelerometers will be collected thereafter. Instructions on the use of the accelerometers will be given. They will also be informed that any personal information will strictly be kept confidential and that the results will be used for analysis in the study.
  2. Written consent will be taken on initial assessment if patient agrees to participate in the study.
  3. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire will be administered. It consists of 15 questions and will take less than 10 minutes to complete.
  4. The patient will undertake 14 sessions of PR under supervision to successfully complete the program. The program is held at Guy's and St Thomas' Hospital.
  5. The PRAISE questionnaire will be administered again after completion of the program. Patients will be asked to wear the accelerometers again to track their physical activity. After 5 to 7 days of use, the accelerometers will be collected either from their address or via stamped postage.

No changes will be made to the current pulmonary rehabilitation program.

No control group is present in the study as pulmonary rehabilitation is the standard of care and it is not ethical to withhold pulmonary rehabilitation from patients with COPD.

The null hypothesis would be that there is no difference in physical activity and self-efficacy before and after pulmonary rehabilitation. The statistical test used will be a paired sample t-test to determine the change in a) physical activity and b)self-efficacy after pulmonary rehabilitation.

Correlation analysis will be made between self-efficacy and physical activity with a) Anxiety and depression (Hospital anxiety and depression scale), b)Functional exercise capacity (6 minute walk test) and c) COPD Assessment test.

A Pearson or Spearman correlations will be done depending on whether or not the data is normally distributed.

研究类型

观察性的

注册 (预期的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • London
      • City of Westminster、London、英国、SE1 7EH
        • 招聘中
        • St. Thomas' Hospital
        • 接触:
        • 首席研究员:
          • Noor Diana Mohamed Sani

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

This study involves patients with chronic obstructive pulmonary disease (COPD), whose diagnosis is confirmed by spirometry

描述

Inclusion Criteria:

  1. Patients who fulfill the current inclusion criteria for referral to pulmonary rehabilitation in Guy's and St Thomas' Hospital.

    • Have chronic obstructive pulmonary disease or other respiratory conditions.
    • Are aware of the about the referral and details of the program.
    • Have consented and are able to attend the program.
  2. A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity < 0.70 after bronchodilator) (GOLD, 2014)

Exclusion Criteria:

  1. No evidence of COPD on spirometry
  2. Acute exacerbations within last 4-6 weeks requiring hospital admission
  3. Evidence of ischemic heart disease/ acute changes on ECG
  4. Uncontrolled hypertension
  5. Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course or limit participation in the course
  6. Lung cancer

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients with COPD
This is an observational study of patients with chronic obstructive pulmonary disease (COPD) who attend pulmonary rehabilitation, which is the routine standard of care in Guy's and St. Thomas' Hospital, London. It lasts for 14 sessions, twice a week and primarily consists of a supervised exercise program and educational sessions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in physical activity level after pulmonary rehabilitation
大体时间:Baseline measurement and after the program (approx Week 10)
Physical activity is measured using the Actigraph accelerometer, which is a small light weight device clipped onto a waist belt. Its output is vector magnitude units, steps, energy expenditure and activity intensity level. Patients will wearing the device for 5 to 7 days, before and after the program. The pulmonary rehabilitation program consists of 14 sessions, twice a week.
Baseline measurement and after the program (approx Week 10)
Change in level of Self-Efficacy using the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire scores
大体时间:Baseline, and after pulmonary rehabilitation program (approx Week 10)
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire is a questionnaire measuring the level of self-efficacy. It consists of 15 questions on a 4-point scale. It takes less than 10 minutes to complete.
Baseline, and after pulmonary rehabilitation program (approx Week 10)

次要结果测量

结果测量
措施说明
大体时间
Change in 6-Minute Walk Test distance after pulmonary rehabilitation
大体时间:Baseline, and after pulmonary rehabilitation program (approx Week 10)
The 6-Minute Walk Test is a test of functional exercise capacity which is routinely used in pulmonary rehabilitation programs.
Baseline, and after pulmonary rehabilitation program (approx Week 10)
Change in Hospital Anxiety and Depression Scale (HADS) questionnaire score
大体时间:Baseline, and after pulmonary rehabilitation program (approx Week 10)
HADS consists of 14 questions and takes less than 10 minutes to complete. It measures the level of anxiety and depression.
Baseline, and after pulmonary rehabilitation program (approx Week 10)
Change in COPD Assessment Test score
大体时间:Baseline, and after pulmonary rehabilitation program (approx Week 10)
The COPD Assessment Test is an 8-item questionnaire which determines the impact of chronic obstructive pulmonary disease on the patient's wellbeing and daily life. It takes less than 5 minutes to complete.
Baseline, and after pulmonary rehabilitation program (approx Week 10)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Noor Diana Mohamed Sani、University College, London
  • 学习椅:Leyla Osman, Dr、University College London, Guy's and St. Thomas' Hospital
  • 研究主任:Lynn McDonnell, MSc、Guy'S and St Thomas' Nhs Foundation Trust

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年4月1日

初级完成 (预期的)

2014年8月1日

研究完成 (预期的)

2014年8月1日

研究注册日期

首次提交

2014年3月11日

首先提交符合 QC 标准的

2014年3月12日

首次发布 (估计)

2014年3月13日

研究记录更新

最后更新发布 (估计)

2014年5月29日

上次提交的符合 QC 标准的更新

2014年5月27日

最后验证

2014年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅