The Impact of Tele-coaching on the Physical Activity Level

Telemedicine Clinical Trial

Official title:

The Impact of Tele-coaching on the Physical Activity Level in Patients With Chronic Respiratory Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05147038
• Other study ID #: 80/2020
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Palacky University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Telemedicine

Intervention

Device:
• Tele-coaching
The participants are instructed to use a "Fitbit" fitness tracker to record the number of steps. This device is compatible with the "m-PAC" App, which was developed for this specific group of participants (individuals suffering from a chronic lung disease). The participants receive a feedback via the "m-PAC" App every day and they also receive a week report to be albe to adjust their step goal. They are asked to increase or keep their week goal every Sunday after reviewing a weekly report. The participants also receive tips for their PA improvement and they are asked for medication change specification (every Wednesday).

Locations

Country	Name	City	State
Czechia	Faculty of Physical Culture, Palacky University Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
Palacky University	KU Leuven

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective measurement of physical activity	Change in weekly mean step count 12 weeks post randomization in the intervention group as compared to the control group.	12 weeks
Secondary	Physical activity parameters	Objectively measured mean daily time in at least moderate intense activity, walking time, movement intensity and activity bout duration.	12 weeks
Secondary	Spirometry 1	Respiratory muscle function 1 (VC = vital capacity, FVC = forced vital capacity, FEV1 = forced expiratory volume at one second [L]).	12 weeks
Secondary	Spirometry 2	Respiratory muscle function 2 (PEF = peak expiratory flow [L/min]).	12 weeks
Secondary	Spirometry 3	Respiratory muscle strength (MIP = maximum inspiratory pressure, MEP = maximum expiratory pressure, P0.1 = airway occlusion pressure [kPa], TTmus = tension time index).	12 weeks
Secondary	Six minute walk test	Functional exercise capacity.	12 weeks
Secondary	Isometric Quadriceps force	Isometric Quadriceps strength measurement.	12 weeks
Secondary	Questionnaire 1	Health status evaluation: 36-Item Short Form Survey (SF-36). There are 8 scales. Each scale is directly transformed into a 0-100 scale (each question carries equal weight). The lower the score is, the more disability it expresses.	12 weeks
Secondary	Questionnaire 2	Interstitial lung disease specific health-related quality of life evaluation: The King's Brief Interstitial Lung Disease (KBILD) questionnaire. A15-item validated questionnaire. The total score ranges from 0-100. There are three domain scores: Psychological, Breathlessness and activities and Chest symptoms. The higher score reflects better health-related quality of life.	12 weeks
Secondary	Questionnaire 3	Anxiety and depression evaluation: Hospital Anxiety and Depression Scale (HADS). There are 14 items. The scoring ranges from 0 to 21. The higher the score, the more severe the anxiety and depression level is.	12 weeks
Secondary	Questionnaire 4	Fatigue evaluation: Multidimensional Assessment of Fatigue (MAF) Scale. It contains 16 items. Scores range from 1 (no fatigue) to 50 (severe fatigue) and the higher score means worse fatigue.	12 weeks