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Exercise Study in Patients With Lung Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01581346
Acronym
POSITIVE
Enrollment
40
Registered
2012-04-20
Start date
2011-03-31
Completion date
2011-12-31
Last updated
2012-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC, exercise intervention, quality of life

Brief summary

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.

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).

Interventions

OTHERExercise 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.

Sponsors

Heidelberg University
CollaboratorOTHER
German Cancer Research Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
- number of patients who are adherent to the exercise intervention8 monthsAdherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.

Secondary

MeasureTime frameDescription
- effects of the exercise intervention on psychological symptoms (e.g. quality of life)8 monthsQuality 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)8 monthsMuscle strength will be measured by hand held dynamometry and endurance by 6 Minute Walk Test

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026