The Impact of Tele-coaching on the Physical Activity Level

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

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.

Study Overview

• Status: Recruiting
• Conditions: Telemedicine
• Intervention / Treatment: Device: Tele-coaching

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamara Zlamalova, MSc.; Phone Number: +420773898849; Email: tamara.zlamalova01@upol.cz

Study Locations

• Czechia
  • Olomouc, Czechia, 77111
    • Recruiting
    • Faculty of Physical Culture, Palacky University Olomouc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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).	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).
No Intervention: Control group; Participants in the control group will receive usual care (including regular visits) together with the educational information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity parameters	Objectively measured mean daily time in at least moderate intense activity, walking time, movement intensity and activity bout duration.	12 weeks
Spirometry 1	Respiratory muscle function 1 (VC = vital capacity, FVC = forced vital capacity, FEV1 = forced expiratory volume at one second [L]).	12 weeks
Spirometry 2	Respiratory muscle function 2 (PEF = peak expiratory flow [L/min]).	12 weeks
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
Six minute walk test	Functional exercise capacity.	12 weeks
Isometric Quadriceps force	Isometric Quadriceps strength measurement.	12 weeks
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
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
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
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

Collaborators and Investigators

• Sponsor: Palacky University
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Physical activity; Tele-coaching
• Other Study ID Numbers: 80/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No