Long-term Activity Coaching in Patients With COPD

NCT04139200 | Completed

• 1 other identifier: S62902
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COPD

Keywords

Physical activity; Tele coaching

Outcome Measures

Primary Outcomes (1)

• Daily number of steps at 12 months

  Change in daily mean step count 12 months post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (\> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.

  12 months

Secondary Outcomes (14)

• Daily number of steps at 6 months

  6 months

• Minutes per day spent in at least moderate intense activities

  6 months and 12 months

• Mean walking time per day

  6 months and 12 months

• Mean sedentary time per day

  6 months and 12 months

• Exercise capacity

  6 months and 12 months

Study Arms (2)

Type 1 tele coaching group

EXPERIMENTAL

Coaching with daily interaction with the coaching application, based on a adaptive physical activity goal

Behavioral: Type 1 physical activity tele coaching intervention

Type 2 tele coaching group

SHAM COMPARATOR

Coaching with fixed physical activity goal and limited interaction with the smartphone application

Behavioral: Type 2 physical activity tele coaching intervention

Interventions

Type 1 physical activity tele coaching intervention BEHAVIORAL

A) Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed. B) Step counter providing direct feedback. C) A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards. D) Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data, failure to progress or change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Type 1 tele coaching group

Type 2 physical activity tele coaching intervention BEHAVIORAL

A) Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity. B) A step counter providing direct feedback. C) A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period). D) Telephone contacts triggered in the case of change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Type 2 tele coaching group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Underwent lung transplantation or active on the lung transplantation list
• Involved in or planned to start with a structured multidisciplinary rehabilitation program

Sponsors & Collaborators

• KU Leuven: lead
• University Ghent: collaborator

Study Sites (2)

UZ Gent

Ghent, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Blondeel A, Hermans F, Breuls S, Wuyts M, Everaerts S, De Maeyer N, Derom E, Janssens W, Demeyer H, Troosters T. A Long-Term Physical Activity Coaching Program for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Dec;211(12):2330-2339. doi: 10.1164/rccm.202501-0170OC.

  PMID: 40700740 DERIVED

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

• Wim Janssens, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Heleen Demeyer, Dr

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Thierry Troosters, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Nikolaas De Maeyer, Dr

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Astrid Blondeel

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Eric Derom, Prof.Dr.

  UZ Gent

  PRINCIPAL INVESTIGATOR

• Fien Hermans

  U Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in the control group will receive a sham version of the smartphone application. Patients are unaware of the difference between the coaching programs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: January 22, 2020
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

BE (2)