The Impact of Tele-coaching on the Physical Activity Level

Sponsor

Palacky University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05147038

Collaborator

KU Leuven (Other)

Enrollment

Location

Arms

15.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Telemedicine	Device: Tele-coaching	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Masking Description:

Neither patients nor investigators will be blinded for the allocation.

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 14, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Culture, Palacky University Olomouc	Olomouc		Czechia	77111

Sponsors and Collaborators

Palacky University
KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zdenek Svoboda, Tamara Zlamalova, Palacký University Olomouc, the Department of Physiotherapy, Principal Investigator, Ph.D. student, Palacky University

ClinicalTrials.gov Identifier:

NCT05147038

Other Study ID Numbers:

80/2020

First Posted:

Dec 7, 2021

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zdenek Svoboda, Tamara Zlamalova, Palacký University Olomouc, the Department of Physiotherapy, Principal Investigator, Ph.D. student, Palacky University

Tele-coaching

Physical activity

Study Results

No Results Posted as of Dec 7, 2021