The Impact of Tele-coaching on the Physical Activity Level

Not Applicable

Completed

• Conditions: Telemedicine
• Interventions: Device: Tele-coaching

• Registration Number: NCT05147038
• Lead Sponsor: Palacky University

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.

Study Timeline

• Study Start: 2021-09-14
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-07
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Tele-coaching	Participants allocated into the intervention group will be coached for 12 weeks by a tele-coaching mobile App containing tips for PA increase and for number of steps recording (visual feedback for the patient).

Primary Outcome Measures

Name	Time	Method
Objective measurement of physical activity	12 weeks	Change in weekly mean step count 12 weeks post randomization in the intervention group as compared to the control group.

Secondary Outcome Measures

Name	Time	Method
Physical activity parameters	12 weeks	Objectively measured mean daily time in at least moderate intense activity, walking time, movement intensity and activity bout duration.
Spirometry 1	12 weeks	Respiratory muscle function 1 (VC = vital capacity, FVC = forced vital capacity, FEV1 = forced expiratory volume at one second \[L\]).
Spirometry 2	12 weeks	Respiratory muscle function 2 (PEF = peak expiratory flow \[L/min\]).
Spirometry 3	12 weeks	Respiratory muscle strength (MIP = maximum inspiratory pressure, MEP = maximum expiratory pressure, P0.1 = airway occlusion pressure \[kPa\], TTmus = tension time index).
Six minute walk test	12 weeks	Functional exercise capacity.
Isometric Quadriceps force	12 weeks	Isometric Quadriceps strength measurement.
Questionnaire 1	12 weeks	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.
Questionnaire 2	12 weeks	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.
Questionnaire 3	12 weeks	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.
Questionnaire 4	12 weeks	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.

Trial Locations

Locations (1)

Faculty of Physical Culture, Palacky University Olomouc; 🇨🇿 Olomouc, Czechia