Physical Activity Intervention and Cardiovascular Risk Markers in COPD

NCT03869112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-03-13

No results posted yet for this study

Summary

The Aim of this study is to examine the feasibility of a future trial comparing the impact of a physical activity intervention and a standard pulmonary rehabilitation programme upon cardiovascular risk and symptoms in COPD. The study involved three groups which are physical activity group, pulmonary rehabilitation group and usual care. The physical activity group and the pulmonary rehabilitation group will complete six-weeks of intervention. The pulmonary rehabilitation group will participate in a standard rehabilitation programme of supervised exercise and education sessions. Physical activity group will be involved in a programme that aims to increase their physical activity level with an increasing step count. Usual care group will be monitored for six-weeks.

Before and after interventions measures will be taken including exercise capacity, body composition, blood tests, arterial stiffness, questionnaires assessing health quality of life, anxiety and depression, symptoms, cardiovascular disease risk.

The investigators will also have a sub-group study. The subgroup study will have two arms interventions which are pulmonary rehabilitation group and physical activity group. The investigators will recruit 10 participants for each group from the main groups' population (no usual care group). Additional before and after measures will be taken for sub-group study and that includes Magnetic resonance imaging (MRI) scanning for adipose visceral tissue and postprandial lipaemic response test.

It is hypothesised that exercise and physical activity level can reduce cardiovascular disease risk with COPD patients, but the relative impact of both interventions need to be explored.

Conditions

Interventions

BEHAVIORAL

Physical activity intervention

Physical activity group will be given a charge 2 FitBit device to monitor their PA specially steps count, step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home-based intervention.

OTHER

Pulmonary rehabilitation group

Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013)

Sponsors & Collaborators

  • Loughborough University

    collaborator OTHER
  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • Sally Singh, Professor · University Hospital of Leicester NHS Tust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-02-01
Completion
2020-02-01

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869112 on ClinicalTrials.gov