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Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

Primary Purpose

Pulmonary Cancer

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
physical exercise and dyspnoea counseling
home training
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Cancer focused on measuring pulmonary cancer, radically operated, exercise training, dyspnea counseling, quality of life, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

supervised exercise training

one instruction on homebased exercises

Arm Description

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

One instruction on home based exercise training and dyspnea management

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2010
Last Updated
October 21, 2015
Sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital, The Danish Cancer Foundation - Research Department - North Region, University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01048762
Brief Title
Multidisciplinary Rehabilitation After Cancer Pulmonis Operation
Official Title
Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital, The Danish Cancer Foundation - Research Department - North Region, University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Cancer
Keywords
pulmonary cancer, radically operated, exercise training, dyspnea counseling, quality of life, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supervised exercise training
Arm Type
Active Comparator
Arm Description
Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training
Arm Title
one instruction on homebased exercises
Arm Type
Sham Comparator
Arm Description
One instruction on home based exercise training and dyspnea management
Intervention Type
Other
Intervention Name(s)
physical exercise and dyspnoea counseling
Other Intervention Name(s)
aerobic exercise training and resistance training, dyspnea counseling, training in groups
Intervention Description
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
Intervention Name(s)
home training
Other Intervention Name(s)
home based exercises
Intervention Description
one instruction in home based exercise training
Primary Outcome Measure Information:
Title
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT
Time Frame
4 months after inclusion
Secondary Outcome Measure Information:
Title
Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT
Time Frame
1 year after inclusion
Title
Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)
Time Frame
4 months and 1 year after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitautas Nekrasas, Chief doctor
Organizational Affiliation
Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark

12. IPD Sharing Statement

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Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

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