The Impact of Tele-coaching on the Physical Activity Level

NCT05147038 | Completed

• 1 other identifier: 80/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemedicine

Keywords

Tele-coaching; Physical activity

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (10)

• Physical activity parameters

  12 weeks

• Spirometry 1

  12 weeks

• Spirometry 2

  12 weeks

• Spirometry 3

  12 weeks

• Six minute walk test

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants in the control group will receive usual care (including regular visits) together with the educational information.

Interventions

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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palacky University: lead
• KU Leuven: collaborator

Study Sites (1)

Faculty of Physical Culture, Palacky University Olomouc

Olomouc, 77111, Czechia

Location

Related Publications (1)

• 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.

  PMID: 38511242 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither patients nor investigators will be blinded for the allocation.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tamara Zlamalova, Palacký University Olomouc, the Department of Physiotherapy, Principal Investigator, Ph.D. student

Model Details: 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).

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 7, 2021
• Study Start: September 14, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)