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OpenTrials
Completed

NCT Number: NCT01987544

Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation

Home ergometer training combined with online monitoring and regular telephone support could prove to be a cost-effective method to improve physical performance and quality of life in COPD patients.

The primary objective of the study is to demonstrate a significantly higher daily workout time in patients that are monitored during home ergometer training with telephone support compared to conventional home ergometer training. Consequently we expect an increased quality of life related to the illness and a decreasing BODE-Index. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

About this study

Hypothesis: There will be an increased prevalence, morbidity and mortality of COPD during the next decades. On the other hand there is a clear correlation between life expectancy and physical activity in this disease. Telemedicine concepts promise new treatment strategies with favourable impact on the long-term process of COPD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • COPD

Exclusion criteria

  • tumor diseases
  • unstable coronary heart disease
  • untreated cardiac valve disease
  • incapable of giving consent

Treatment and study plan

Ergometer Training

Other

Other names: Ergometer

Motivation

Other

Other names: Telemonitoring, Phone Calls

Primary outcomes

  1. Training time

    Time frame: 3 month

    Patients workout at home with a provided bicycle ergometer, the daily training target is 30 minutes. The training time is monitored online using a GSM module.

Secondary outcomes

  1. BODE-Index

    Time frame: 3 month

    The BODE-Index is a grading tool to assess the progress of COPD with a range of 0 to 10 points. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

Other outcomes

  1. CAT (COPD Assessment Test)

    Time frame: 3 month

    The CAT is a questionnaire to measure the impact of COPD on a person's life. The range is 0 to 40 points.

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • Vitaphone GmbH

Registry information

Official study title

German: Effekte Eines Telemonitorisch überwachten Ergometertrainings Bei Patienten Mit Einer COPD Nach Exazerbation: Eine Prospektiv Randomisierte Studie

Acronym: COPD

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 19, 2013
Registry last updated
Feb 25, 2016

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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