Enhancing Physical Activity in Patients With Interstitial Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2022-01-06

Brief Summary

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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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Detailed Description

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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.

Conditions

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Interstitial Lung Disease Interstitial Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tele coaching group

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

Group Type EXPERIMENTAL

Tele coaching intervention

Intervention Type 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.

Usual care group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tele coaching intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No