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TelemedicineNCT05147038

The Impact of Tele-coaching on the Physical Activity Level

A study testing Tele-coaching in people with Telemedicine, run by Palacky University at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Telemedicine
What is being tested?
Tele-coaching
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCzechia
Study dates
14 Sep 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Faculty of Physical Culture, Palacky University Olomouc

    Olomouc, 77111

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Conditions
Telemedicine
Being tested
Tele-coaching
Keywords
Tele-coaching, Physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-coachingDevice

    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).

Study groups in NCT05147038
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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).
Receives: Device: Tele-coaching
Control groupNo interventionParticipants in the control group will receive usual care (including regular visits) together with the educational information.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Physical activity parameters

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

    Measured: 12 weeks

  2. Spirometry 1

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

    Measured: 12 weeks

  3. Spirometry 2

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

    Measured: 12 weeks

  4. Spirometry 3

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

    Measured: 12 weeks

  5. Six minute walk test

    Functional exercise capacity.

    Measured: 12 weeks

  6. Isometric Quadriceps force

    Isometric Quadriceps strength measurement.

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

  10. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2021
  2. Study start14 Sep 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147038
Sponsor's protocol ID
80/2020
Status last verified
Feb 2023
First submitted
9 Nov 2021
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Breuls S, Zlamalova T, Raisova K, Blondeel A, Wuyts M, Dvoracek M, Zurkova M, Yserbyt J, Janssens W, Wuyts W, Troosters T, Demeyer H. Physical activity coaching in patients with interstitial lung diseases: A randomized controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241235231. doi: 10.1177/14799731241235231.

    PubMed 38511242

Questions about this trial

What is this clinical trial studying?

A study testing Tele-coaching in people with Telemedicine, run by Palacky University at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective measurement of physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147038, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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