Enhancing Physical Activity in Patients With Interstitial Lung Disease

NCT04138173 | Completed

• 1 other identifier: S62505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in patients with chronic respiratory diseases such as COPD and more recently Idiopathic Pulmonary Fibrosis. Physical inactivity is a common feature of patients with chronic respiratory diseases. Whereas pulmonary rehabilitation is known to result in benefits in exercise capacity, symptoms and quality of life, these gains will not automatically translate into increases in physical activity. Therefore, the present study aims to investigate the effect of a physical activity coaching program on the physical activity level of patients with interstitial lung disease.

Conditions

Interstitial Lung Disease; Interstitial Pulmonary Fibrosis

Keywords

physical activity; tele coaching

Outcome Measures

Primary Outcomes (1)

• Daily number of steps at 12 weeks

  Change in weekly mean step count 12 weeks 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 (Dynaport Movemonitor) validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis. A measurement will be considered valid when having more than four valid days.

  12 weeks

Secondary Outcomes (8)

• Time spent in at least moderate intense activity

  12 weeks

• Mean walking time per day

  12 weeks

• Movement intensity

  12 weeks

• Activity bout duration

  12 weeks

• Exercise capacity

  12 weeks

Other Outcomes (3)

• Physical activity from a patient's perspective (Exploratory endpoint)

  12 weeks

• Time to first hospital admission

  2 year

• Transplantation free survival

  2 year

Study Arms (2)

Tele coaching group

EXPERIMENTAL

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

Behavioral: Tele coaching intervention

Usual care group

NO INTERVENTION

Usual care

Interventions

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. D.Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data or failure to progress. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Tele coaching group

Eligibility Criteria

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

You may qualify if:

• Stable patients, older than 18 year, with a diagnosis of interstitial lung disease
• Understand and able to work with a smartphone application, as judged by the investigator
• On stable pharmacotherapy
• DLCO ≥30%predicted

You may not qualify if:

• On the waiting list for a lung transplantation
• Life expectancy below 3 months
• Respiratory tract infection or an exacerbation or change in maintenance medication within 4 weeks before study enrolment
• Extra pulmonary impairments, unrelated to the underlying lung disease, interfering with physical activity

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KULeuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Breuls S, Zlamalova T, Raisova K, Blondeel A, Wuyts M, Dvoracek M, Zurkova M, Yserbyt J, Janssens W, Wuyts W, Troosters T, Demeyer H. Physical activity coaching in patients with interstitial lung diseases: A randomized controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241235231. doi: 10.1177/14799731241235231.

  PMID: 38511242 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Thierry Trooosters, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Heleen Demeyer, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Wim Janssens, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Wim Wuyts, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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 9, 2019
• First Posted: October 24, 2019
• Study Start: January 14, 2020
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

BE (1)