Exercise Study in Patients With Lung Cancer (POSITIVE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Other: Exercise intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer |
- - number of patients who are adherent to the exercise intervention [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.
- - effects of the exercise intervention on psychological symptoms (e.g. quality of life) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]Quality of life will be measured by the standardized and validated questionnaire FACT-L;
- - effects of the exercise intervention on physical symptoms (muscle strength and endurance) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]Muscle strength will be measured by hand held dynamometry and endurance by 6 Minute Walk Test
| Enrollment: | 40 |
| Study Start Date: | March 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |
| Thoracic Oncology Clinic for Thoracic Diseases | |
| Heidelberg, Germany, 69126 | |
| Principal Investigator: | Michael Thomas, MD | University of Heidelberg |
More Information
No publications provided
| Responsible Party: | German Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT01581346 History of Changes |
| Other Study ID Numbers: | POSITIVE_II |
| Study First Received: | April 5, 2012 |
| Last Updated: | April 18, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by German Cancer Research Center:
|
NSCLC exercise intervention quality of life |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013