Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

NCT ID: NCT01048762

Last Updated: 2015-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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supervised exercise training

Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training

Group Type ACTIVE_COMPARATOR

physical exercise and dyspnoea counseling

Intervention Type OTHER

Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.

home training

Intervention Type OTHER

one instruction in home based exercise training

one instruction on homebased exercises

One instruction on home based exercise training and dyspnea management

Group Type SHAM_COMPARATOR

home training

Intervention Type OTHER

one instruction in home based exercise training

Interventions

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physical exercise and dyspnoea counseling

Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.

Intervention Type OTHER

home training

one instruction in home based exercise training

Intervention Type OTHER

Other Intervention Names

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aerobic exercise training and resistance training dyspnea counseling training in groups home based exercises

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

The Danish Cancer Foundation - Research Department - North Region

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Barbara C. Brocki

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vitautas Nekrasas, Chief doctor

Role: STUDY_CHAIR

Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital

Locations

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Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Tp.afd-001

Identifier Type: -

Identifier Source: org_study_id

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