Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

Phase 2

Completed

• Conditions: Pulmonary Cancer
• Interventions: Other: home training; Other: physical exercise and dyspnoea counseling

• Registration Number: NCT01048762
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

Detailed Description

Patients who are radically operated for pulmonary cancer report suffering from respiratory problems, mostly dyspnoea, 5 years after operation. Dyspnoea restricts their physical capability and leads to poorer physical, social and mental wellbeing. The effects of training programs on physical and mental wellbeing for cancer patients are well documented. Most of the studies are though performed on patients suffering from breast, colon and prostate cancer. There are only few studies addressing patients with pulmonary cancer. They are mostly focused on short term effects of exercise training on quality of life, with no control group included in the trials. These studies target patients after different forms for treatment, including surgery, chemotherapy and radiation. There is no data referring to quality of life of patients who are radically operated for pulmonary cancer.

Comparison: multidisciplinary group intervention consisting of exercise training and dyspnoea counseling, 10 times, once a week, compared with one instruction in exercise training and dyspnoea counseling. Exercise training is given by a physiotherapist. Both groups receive in addition standard treatment, which is up to 3 counseling sessions with a nurse.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2010-01
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Study Completion: 2010-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital

Exclusion Criteria

• not radically operated
• cannot speak and read Danish
• cannot cooperate in tests due to poor mental health
• patients who undergo rehabilitation at other centres
• cannot perform walking test due to physical impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one instruction on homebased exercises	home training	One instruction on home based exercise training and dyspnea management
supervised exercise training	physical exercise and dyspnoea counseling	Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training
supervised exercise training	home training	Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training

Primary Outcome Measures

Name	Time	Method
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT	4 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)	4 months and 1 year after inclusion
Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT	1 year after inclusion

Trial Locations

Locations (1)

Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital; 🇩🇰 Aalborg, Denmark