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Completed

NCT Number: NCT01581346

Exercise Study in Patients With Lung Cancer

In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thoracic Oncology Clinic for Thoracic Diseases

Heidelberg, 69126, Germany

About this study

In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients
  • histological confirmed diagnosis of Non small cell lung cancer (NSCLC)
  • current treatment: chemo-and/or radiotherapy
  • age > 18y
  • Body Mass Index (BMI) > 18
  • written informed consent

Exclusion criteria

  • acute infection
  • immobility > 2 days
  • severe neurological impairment
  • severe cardiac impairment
  • severe pulmonal impairment
  • severe renal impairment
  • acute bleedings
  • alcohol-/drug-abuse

Treatment and study plan

Exercise intervention

Other

Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks.

Primary outcomes

  1. - number of patients who are adherent to the exercise intervention

    Time frame: 8 months

    Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.

Secondary outcomes

  1. - effects of the exercise intervention on psychological symptoms (e.g. quality of life)

    Time frame: 8 months

    Quality of life will be measured by the standardized and validated questionnaire FACT-L;

  2. - effects of the exercise intervention on physical symptoms (muscle strength and endurance)

    Time frame: 8 months

    Muscle strength will be measured by hand held dynamometry and endurance by 6 Minute Walk Test

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Heidelberg University

Registry information

Official study title

Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer

Acronym: POSITIVE

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 20, 2012
Registry last updated
Apr 20, 2012

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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