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OpenTrials
Completed

NCT Number: NCT02702791

Sustaining Training Effects Through Physical Activity

This randomized control trial will investigate whether the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge.

After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be randomized to either an intervention group which receives an additional telecoaching program on top of the pulmonary rehabilitation, or to the usual care group, which only receives rehabilitation program. Apart from the added telecoaching program to the intervention group, the rehabilitation program will be identical and last for another three months (2 times a week). After discharge, both groups will be followed up for six months.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a primary diagnosis of COPD according to internationally accepted guidelines
  • Patients that completed three months of the outpatient pulmonary rehabilitation program of Gasthuisberg University Hospital (Leuven, Belgium)
  • Current or previous smoking exposure of at least 10 pack years
  • Ability to manage electronic devices (smartphone, step counter)

Exclusion criteria

  • Other predominant respiratory diseases than COPD (asthma, pulmonary hypertension)
  • Orthopedic, neurological and muscular co morbidities that could interfere with normal biomechanical movement patterns and the ability to increase physical activity levels
  • Patients on the waiting list for lung transplantation

Treatment and study plan

Telecoaching

Behavioral

Pedeometer based goals and telecoaching support

Pulmonary Rehabilitation

Other

Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.

Primary outcomes

  1. Changes in physical activity (number of steps)

    Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up

Secondary outcomes

  1. Changes in physical activity (time spent in moderate activity)

    Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up

  2. Changes in pulmonary rehabilitation outcomes (Quadriceps force)

    Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up

  3. Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)

    Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up

  4. Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)

    Time frame: At three and six months of pulmonary rehabilitation and six months of follow up

  5. Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)

    Time frame: At three and six months of pulmonary rehabilitation and six months of follow up

  6. Changes in pulmonary rehabilitation outcomes (Quality of life)

    Time frame: At three and six months of pulmonary rehabilitation and six months of follow up

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Enhancing Physical Activity to Achieve Sustainable Benefits in Extrapulmonary Consequences of COPD

Acronym: STEP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2016
Registry last updated
Oct 24, 2019

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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