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临床试验/NCT06330623
NCT06330623已完成不适用

Developing Personalised, Relative Intensity Physical Activity Thresholds for Accelerometer-Derived Measures of Physical Activity in COPD (IMPACT)

University of Leicester2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Phase 1 - Semi-structured Interviews

研究概览

简要总结

The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.

The main questions this study aims to answer are:

  • Phase 1: What does physical activity (intensity) mean to people with COPD?
  • Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD?

Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires.

Phase 2:

Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class.

Sub-study:

Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity.

详细描述

Physical activity (PA) helps prevent and manage non-communicable diseases such as chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) has been shown to benefit people living with COPD by reducing breathlessness, increasing muscle strength, and improving the management of exacerbations. However, the improvement in PA in individuals with COPD remains inconsistent following PR. Despite the personalised nature of PA prescription during PR, the evaluation of free-living PA data has been limited to a 'one size fits all' approach using absolute intensity categories. Reduced exercise tolerance can result in PA being perceived at a high intensity relative to a person's exercise capacity, despite the absolute intensity being low. Exploring both the relative and absolute intensity of PA could offer additional insights and clinical relevance for the evaluation of physical activity in COPD populations.

The aim of this research is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity PA in a user-friendly format for PR teams and service users.

Phase 1 objective: To explore what PA means to people with COPD in the context of relative intensity and pulmonary rehabilitation.

Phase 2 objective: To examine the differences between time spent in physical activity intensity expressed in absolute and relative terms for people with COPD.

Phase 1: Semi-structured interviews will take place where participants will discuss their COPD and their perceptions of physical activity and relative intensity. The interviews will be in person (Biomedical research centre, Leicester) or over the phone/video call. The participants will complete several questionnaires about respiratory symptoms. Before taking part in the interviews, participants will also be asked to take pictures, using a camera provided, of when they are doing physical activity. This will be for a 7 day period before the interview.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Willing and able to provide informed consent for participation in the research.
  • The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria (Agustí et al., 2023).
  • Male or female, aged 40+ years
  • Able to communicate in written and spoken English.

排除标准

  • Unable to provide valid informed consent.
  • Severe psychiatric disorders
  • Aged less than 40 years
  • Unable to understand written or spoken English.
  • Inclusion Criteria:
  • Willing and able to provide informed consent for participation in the research.
  • The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria.
  • The patient is referred for PR at the UHL.
  • Male or female, aged 40+ years
  • Able to communicate in written and spoken English
  • Exclusion Criteria:
  • Unable to provide valid informed consent.
  • Lack of motivation to participate in PR programme.
  • Any-contra-indications absolute or relative to exercise training.
  • Has had a cardiac event within last 6 weeks
  • Severe psychiatric disorders
  • Patients with a history of MRSA +ve screens (patients can be assessed and given an exercise programme but cannot attend the classes. Patients need to have 3 consecutive -ve MRSA swabs before they can attend).
  • Aged less than 40 years
  • Unable to understand written or spoken English.

研究组 & 干预措施

Phase 1 Cohort

These participants will be recruited from:

  • Previous research studies
  • COPD nursing ward
  • Pulmonary rehabilitation

Phase 2 Cohort

These participants will be recruited from the pulmonary rehabilitation service.

结局指标

主要结局

Phase 1 - Semi-structured Interviews

时间窗: 30-45 minutes

Semi-structured interview with individuals with COPD

Phase 2 - Differences between time spent in PA intensity expressed in absolute and relative intensity.

时间窗: 8 days

Differences between time spent in PA intensity expressed in absolute and relative using activity monitors (wrist and waist) for eight days before and after the PR programme.

次要结局

  • Phase 1 - Medical Research Council (MRC) Dyspnoea Scale(2 minutes)
  • Phase 1 - COPD Assessment Test (CAT)(5 minutes)
  • Phase 1 - Chronic Respiratory Questionnaire (CRQ-SR)(5 minutes)
  • Phase 1 - Photovoice and photo-elicitation(7 days)
  • Phase 2 - Medical Research Council (MRC) Dyspnoea Scale(2 minutes)
  • Phase 2 - COPD Assessment Test (CAT)(5 minutes)
  • Phase 2 - Chronic Respiratory Questionnaire (CRQ-SR)(5 minutes)
  • Phase 2 - Gait Analysis(45 minutes)
  • Phase 2 - Exercise Capacity (ISWT)(30-45 minutes)
  • Phase 2 - Exercise Capacity (ESWT)(15-30 minutes)
  • Phase 2 - Clinical PROactive Physical Activity instrument in COPD (C-PPAC)(5 minutes)
  • Phase 2 - Photovoice and photo-elicitation(8 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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