Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

Pulmonary Cancer Clinical Trial

Official title:

Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048762
• Other study ID #: Tp.afd-001
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2010
• Last updated: October 21, 2015
• Start date: February 2006
• Est. completion date: September 2010

Study information

• Verified date: October 2015
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Cancer

Intervention

Other:
• 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.
• home training
one instruction in home based exercise training

Locations

Country	Name	City	State
Denmark	Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Aarhus University Hospital, The Danish Cancer Foundation - Research Department - North Region, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT		4 months after inclusion	No
Secondary	Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT		1 year after inclusion	No
Secondary	Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)		4 months and 1 year after inclusion	No