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Enhancing Physical Activity in Patients With Interstitial Lung Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04138173
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	KU Leuven
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Thierry Trooosters, ProfHeleen Demeyer, ProfWim Janssens, ProfWim Wuyts, Prof
Principal Investigator Affiliation	KU LeuvenKU LeuvenKU LeuvenKU Leuven
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease, Interstitial Pulmonary Fibrosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Tele coaching group

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

No Intervention: Usual care group

Usual care

Interventions

Behavioral: - 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.

Contact a Trial Team

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