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Completed

NCT Number: NCT05147038

The Impact of Tele-coaching on the Physical Activity Level

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.

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Key information

Conditions

Telemedicine Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Culture, Palacky University Olomouc

Olomouc, 77111, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-coaching

Device

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).

Primary outcomes

  1. Objective measurement of physical activity

    Time frame: 12 weeks

    Change in weekly mean step count 12 weeks post randomization in the intervention group as compared to the control group.

Secondary outcomes

  1. Physical activity parameters

    Time frame: 12 weeks

    Objectively measured mean daily time in at least moderate intense activity, walking time, movement intensity and activity bout duration.

  2. Spirometry 1

    Time frame: 12 weeks

    Respiratory muscle function 1 (VC = vital capacity, FVC = forced vital capacity, FEV1 = forced expiratory volume at one second [L]).

  3. Spirometry 2

    Time frame: 12 weeks

    Respiratory muscle function 2 (PEF = peak expiratory flow [L/min]).

  4. Spirometry 3

    Time frame: 12 weeks

    Respiratory muscle strength (MIP = maximum inspiratory pressure, MEP = maximum expiratory pressure, P0.1 = airway occlusion pressure [kPa], TTmus = tension time index).

  5. Six minute walk test

    Time frame: 12 weeks

    Functional exercise capacity.

  6. Isometric Quadriceps force

    Time frame: 12 weeks

    Isometric Quadriceps strength measurement.

  7. Questionnaire 1

    Time frame: 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.

  8. Questionnaire 2

    Time frame: 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.

  9. Questionnaire 3

    Time frame: 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.

  10. Questionnaire 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Palacky University

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2021
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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