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Clinical Trials/NCT05147038
NCT05147038
Completed
Not Applicable

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

Palacky University1 site in 1 country40 target enrollmentStarted: September 14, 2021Last updated:
ConditionsTelemedicine

Overview

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Objective measurement of physical activity

Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Masking Description

Neither patients nor investigators will be blinded for the allocation.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Physical activity parameters(12 weeks)
  • Spirometry 1(12 weeks)
  • Spirometry 2(12 weeks)
  • Spirometry 3(12 weeks)
  • Six minute walk test(12 weeks)
  • Isometric Quadriceps force(12 weeks)
  • Questionnaire 1(12 weeks)
  • Questionnaire 2(12 weeks)
  • Questionnaire 3(12 weeks)
  • Questionnaire 4(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zdenek Svoboda

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

Palacky University

Study Sites (1)

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