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NCT04139200Completed

Long-term Activity Coaching in Patients With COPD

The Long-term Effects of a Tele Coaching Intervention in Patients With COPD: a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 19 Jan 2024

Brief summary (registry, in English)

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of mortality and morbidity around the world. Studies revealed that patients with COPD are less active than age-matched healthy controls and activity level decreases with disease severity. Higher levels of physical activity is related to important health-related outcomes, such as lower mortality rate and hospital admissions. Additionally, increasing physical activity is related with substantial health benefits. Patients with COPD have a higher risk of developing insulin resistance, hypertension, dyslipidemia, osteopenia, leading to chronic diseases such as coronary heart disease, type 2 diabetes and osteoporosis, which have been related to physical inactivity in the healthy population. Moreover, physical inactivity has been related to the occurrence of comorbidities in patients with COPD. Therefore, improving physical activity levels is a recommended treatment in the disease management in all patients with COPD and is implemented in the recent GOLD guidelines for all patients with COPD, regardless of the disease severity. The research group investigated the effect of a 3-month semi-automatic tele-coaching intervention on physical activity levels in patients with COPD. The tele coaching intervention led to a significant improvement on physical activity in the intervention group. Although this trial showed positive results on physical activity, further research is needed, mainly to investigate the long-term (12 months) effectiveness of such interventions and the added value of a smartphone application on top of a simple step counter providing feedback. Additionally, since physical activity is related to the development of comorbidities, the investigators aim to explore the influence of improving physical activity levels on the occurrence of cardiovascular, metabolic and musculoskeletal comorbidities. Finally, this study will explore baseline characteristics (such as social support, self-efficacy, dynamic hyperinflation, etc.) that can predict success in this intervention.

Status (registry)
Completed
Study type
Interventional
Enrollment
150 (actual)
First submitted
23 Oct 2019
Start date
22 Jan 2020
Primary completion date
11 Dec 2023
Lead sponsor
KU Leuven
Diseases
COPD
NCT number
NCT04139200

What you commit to

  • Study type: Interventional
  • Participants enrolled: 150
  • From 22 Jan 2020 to the primary completion date, 11 Dec 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Underwent lung transplantation or active on the lung transplantation list

Other

  • The presence of orthopedic or other problems not allowing an increase in physical activity levels
  • Unable to learn to work with a new electronic device (e.g. smartphone), as judged by the investigator
  • Involved in or planned to start with a structured multidisciplinary rehabilitation program

Who the study is looking for

  • Patients diagnosed with COPD (GOLD criteria post bronchodilator FEV1/FVC \< 0.70)
  • Patients under medical follow-up of a respiratory physician or general practitioner with no moderate (ambulatory treated) and/or severe (requiring a hospital admission) exacerbation in the past month
  • Older than 40 years old
  • Smoking history with more than 10 pack years

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UZ Gent
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.