---
title: Enhancing Physical Activity in Patients With Interstitial Lung Disease
nct_id: NCT04138173
overall_status: COMPLETED
phase: NA
sponsor: KU Leuven
study_type: INTERVENTIONAL
primary_condition: Interstitial Lung Disease
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04138173.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04138173"
ct_last_update_post_date: 2022-03-18
last_seen_at: "2026-05-12T07:05:09.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Enhancing Physical Activity in Patients With Interstitial Lung Disease

**Official Title:** Enhancing Physical Activity in Patients With Interstitial Lung Disease: an Exploratory Randomized Controlled Trial

**NCT ID:** [NCT04138173](https://clinicaltrials.gov/study/NCT04138173)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** KU Leuven
- **Conditions:** Interstitial Lung Disease, Interstitial Pulmonary Fibrosis
- **Start Date:** 2020-01-14
- **Completion Date:** 2022-01-06
- **CT.gov Last Update:** 2022-03-18

## 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.

## Detailed Description

The present study aims to

1\) primary objective: To explore the magnitude of the effect of a semi-automated tele coaching intervention to enhance physical activity in patients with interstitial lung disease, as measured at 12 weeks, expressed as mean daily step count.

2\) Secondary objectives:

1. To test the magnitude of the effect of a 12 weeks coaching intervention on mean time in at least moderate intense activity, walking time, movement intensity, activity bout duration, exercise capacity, quadriceps force and health status.
2. To investigate the patient's experience with this intervention
3. To test the effect of a 12 weeks coaching intervention on the physical activity from a patient experience.
4. To explore the relation between physical activity and vitamin D

Therefore, the study will include stable patients with interstitial lung disease who will be randomized into an intervention (semi-automated coaching intervention) and control (usual care) group. The study consists of a total of 3 visits.

* visit 1: Screening visit
* visit 2: Randomization visits, scheduled 1-2 weeks after visit 1
* visit 3: Follow-up visit, schedules 12 weeks after visit 2

Patients will be randomized into the intervention and control group. In both groups patients will receive information about the importance of being physically active and the physical activity recommendations provided by the world health organization. This information will be provided in a leaflet that will be discussed in an education session (one-to-one) of 10-15 minutes.

1. The control group will receive usual care together with the educational information.
2. Patients in the intervention group will receive a multicomponent tele coaching intervention that consists of 1) education about the importance of physical activity and a one-to-one interview with the coach discussing motivation and barriers to be active, 2) a step counter providing direct feedback, 3) application installed on a smartphone providing an adaptive goal and daily and weekly feedback and 4) contact with the coach if the patient is not compliant with the intervention or not increasing physical activity. The patient is asked to have a daily interaction with the smartphone application.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

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

## Arms

- **Tele coaching group** (EXPERIMENTAL) — Coaching with daily interaction with the coaching application, based on an adaptive physical activity goal
- **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.

## Primary Outcomes

- **Daily number of steps at 12 weeks** _(time frame: 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.

## Secondary Outcomes

- **Time spent in at least moderate intense activity** _(time frame: 12 weeks)_
- **Mean walking time per day** _(time frame: 12 weeks)_
- **Movement intensity** _(time frame: 12 weeks)_
- **Activity bout duration** _(time frame: 12 weeks)_
- **Exercise capacity** _(time frame: 12 weeks)_
- **Maximal voluntary isometric quadriceps force** _(time frame: 12 weeks)_
- **Health status** _(time frame: 12 weeks)_
- **Symptoms of anxiety and depression** _(time frame: 12 weeks)_

## Locations (1)

- KULeuven, Leuven, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.kuleuven|leuven||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04138173.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04138173*  
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