The Impact of Tele-coaching on the Physical Activity Level

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-term Activity Coaching in Patients With COPD

NCT04139200

COPD

COMPLETED NA

Enhancing Physical Activity in Patients With Interstitial Lung Disease

NCT04138173

Interstitial Lung Disease Interstitial Pulmonary Fibrosis

COMPLETED NA

Sustaining Training Effects Through Physical Activity

NCT02702791

Pulmonary Disease, Chronic Obstructive

COMPLETED NA

Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)

NCT01349608

Chronic Obstructive Pulmonary Disease Physical Activity Health Behavior

COMPLETED NA

Physical Activity Intervention and Cardiovascular Risk Markers in COPD

NCT03869112

Cardiovascular Diseases Cardiovascular Risk Factor COPD

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Telemedicine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Neither patients nor investigators will be blinded for the allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Tele-coaching

Intervention Type 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).

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No