Exercise Study in Patients With Lung Cancer (POSITIVE)

April 18, 2012 updated by: German Cancer Research Center

Pilot Study to Establish an Exercise Intervention 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69126
        • Thoracic Oncology Clinic for Thoracic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise intervention
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.
Other: Exercise intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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;
8 months
- 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
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Collaborators

Heidelberg University

Investigators

  • Principal Investigator: Michael Thomas, MD, Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSITIVE_II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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