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Completed

NCT Number: NCT04138173

Enhancing Physical Activity in Patients With Interstitial Lung Disease

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.

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Key information

Conditions

Interstitial Lung Disease Behavior Fibrosis Interstitial Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KULeuven

Leuven, 3000, Belgium

About this study

The present study aims to

  • 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.
  • Secondary objectives:
  • 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.
  • To investigate the patient's experience with this intervention
  • To test the effect of a 12 weeks coaching intervention on the physical activity from a patient experience.
  • 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.

  • The control group will receive usual care together with the educational information.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

  1. 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

  1. Time spent in at least moderate intense activity

    Time frame: 12 weeks

    Change in daily time spent in at least moderate intense activity 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 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.

  2. Mean walking time per day

    Time frame: 12 weeks

    Change in mean daily walking time 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 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.

  3. Movement intensity

    Time frame: 12 weeks

    Change in mean movement intensity 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 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.

  4. Activity bout duration

    Time frame: 12 weeks

    Change in mean duration of an activity bout 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 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.

  5. Exercise capacity

    Time frame: 12 weeks

    Change in six-minutes walk distance 12 weeks post randomization in the intervention group as compared to the control group. The six-minute walking test will be performed with standardized encouragement to assess patients' functional exercise capacity. The best of two measurements will be used.

  6. Maximal voluntary isometric quadriceps force

    Time frame: 12 weeks

    Change in isometric quadriceps force 12 weeks post randomization in the intervention group as compared to the control group. The quadriceps isometric strength will be evaluated by a maximal voluntary contraction using the Biodex, a computerized dynamometer. Patients will be seated with a 90° hip and 60° knee flexion. The best of 3 measurements will be taken into analysis as the maximal force capacity of the lower limb.

  7. Health status

    Time frame: 12 weeks

    Health status will be measured by the The King's Brief Interstitial Lung disease (K-BILD) questionnaire. The K-BILD questionnaire is a valid self-completed health status measure for patients with interstitial lung disease consisting of 15 items that measures health status in 3 domains (Psychological, Breathlessness and activity and chest symptoms) and a total score.

  8. Symptoms of anxiety and depression

    Time frame: 12 weeks

    Symptoms of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale (HADs). The HADs is a generic screening measure of symptoms of anxiety and depression. The HADS is a 14 item measure comprising 7 anxiety items and 7 depression items from which separate anxiety and depression sub-scale scores are calculated.

Other outcomes

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

    Time frame: 12 weeks

    The c-PPAC, a 12-item questionnaire assessing physical activity from a patient's perspective reflecting the past 7 days will be collected. The questionnaire investigates the amount of and difficulty with physical activity as perceived by the patient. The 2 domain scores (i.e. amount and difficult) as well as the total score will be retrieved as outcomes.

  2. Time to first hospital admission

    Time frame: 2 year

    For explanatory purposes, time to first hospital admissions will be collected in these patients in the 2 years following on the present study.

  3. Transplantation free survival

    Time frame: 2 year

    For explanatory purposes, transplantation free survival status will be collected in these patients in the 2 years following on the present study.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2019
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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