Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Aalborg University Hospital
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
supervised exercise training
Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training
Intervention: physical exercise and dyspnoea counseling (Other)
supervised exercise training
Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training
Intervention: home training (Other)
one instruction on homebased exercises
One instruction on home based exercise training and dyspnea management
Intervention: home training (Other)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Barbara C. Brocki
Physiotherapist
Aalborg University Hospital