Clinical trial NCT05147038: The Impact of Tele-coaching on the Physical Activity Level
Official title: The Impact of Tele-coaching on the Physical Activity Level in Patients With Chronic Respiratory Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: Tele-coaching
Physical activity
Lead sponsor: Palacky University
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2021-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study group is divided into the intervention and control group. A randomisation was stratified according to the disease (Idiopathic Pulmonary Fibrosis (IPF) and non-IPF). At first, the participants undergo an initial assessment including a respiratory muscle function and strength testing, physical activity measurement, fatigue, depression status, overall quality of life, disease status, exercise capacity and isometric quadriceps muscle strength testing. Both groups will receive information about the importance of being physically active and the PA recommendations provided by the World Health Organization (leaflet discussed in an education session (one-to-one) of 10-15 minutes). The intervention and control periods are followed by a final assessment (exactly the same as the initial one).
Primary purpose: SCREENING

Brief summary: The study aims to test the benefits of a semi-automated tele-coaching program to coach adult participants with chronic lung disease towards a more active lifestyle.

Detailed description: The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in individuals with chronic respiratory diseases, for instance Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF). Physical inactivity and sedentary behavior is a common feature of patients with chronic respiratory diseases. Pulmonary rehabilitation is known as a beneficial intervention in exercise capacity, disease symptoms and quality of life in respiratory diseases. Despite the overall large benefits on exercise capacity and other variables described above, it does not automatically translate into increases in PA. Recent literature shows that coaching programs specifically aiming to increase PA are more likely to result in PA changes.

Therefore, this study was designed to investigate the impact of 3-month (12 weeks) tele-coaching intervention on PA level of adult participants suffering from a chronic lung disease.

Eligibility criteria: Inclusion Criteria:

* Stable patients, older than 18 years of age, with a diagnosis of interstitial lung disease
* Understands and is able to work with a smart phone application (judged by the investigator)
* On stable pharmacotherapy
* Diffusing capacity of the lungs for carbon monoxide (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

Primary outcomes:
measure: Objective measurement of physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical activity parameters
timeFrame: 12 weeks
measure: Spirometry 1
timeFrame: 12 weeks
measure: Spirometry 2
timeFrame: 12 weeks
measure: Spirometry 3
timeFrame: 12 weeks
measure: Six minute walk test
timeFrame: 12 weeks
measure: Isometric Quadriceps force
timeFrame: 12 weeks
measure: Questionnaire 1
timeFrame: 12 weeks
measure: Questionnaire 2
timeFrame: 12 weeks
measure: Questionnaire 3
timeFrame: 12 weeks
measure: Questionnaire 4
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Faculty of Physical Culture, Palacky University Olomouc
Study officials:
References: