Developing Personalised Relative Physical Activity Thresholds in COPD.

NCT06330623 | Recruiting

• 2 other identifiers: 0929321895
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Absolute Intensity; Activity Monitors; Chronic Obstructive Pulmonary Disease; Exercise Capacity; Physical Activity; Relative Intensity

Outcome Measures

Primary Outcomes (2)

• Phase 1 - Semi-structured Interviews

  Semi-structured interview with individuals with COPD

  30-45 minutes

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

  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.

  8 days

Secondary Outcomes (12)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1: Patients from the COPD nursing ward, previous research studies and pulmonary rehabilitation programme. Phase 2: Patients from the pulmonary rehabilitation programme.

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide valid informed consent.
• Severe psychiatric disorders
• Aged less than 40 years
• Unable to understand written or spoken English.
• Phase 2:
• 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
• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

NIHR Leicester Biomedical Research Centre - Respiratory

Leicester, Leicestershire, LE67 2DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• University of Leicester University of Leicester

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phoebe H Lloyd-Evans

CONTACT

+441162502758; phile1@leicester.ac.uk

Mark W Orme

CONTACT

mwo4@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 26, 2024
• Study Start: November 22, 2023
• Primary Completion: March 30, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)