The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050945
• Other study ID #: H-2-2013-150
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: April 19, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of the present project is to investigate the physiological effects of two different types of exercise training in COPD patients. The patients will be examined before, during and after 8 weeks of training to evaluate the effect of different types of skeletal muscle stimulation on health related quality of life, 6 min walking distance, flow mediated dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity, fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will test the hypothesis that:

Resistance training is superior to endurance training in patients with COPD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• FEV1/FVC fixed ratio <0.70, FEV1: <60% of predicted and MRC > or equal to 3

• Arterial oxygen saturation at rest> 90%, BMI >18, LVEF> 45.

• Age: 40 - 80 years

The medical treatment will be continued unchanged during the study and additional prednisolone and /or antibiotic treatment will be prescribed in case of acute exacerbation.

Exclusion Criteria:

• Unstable ischemic heart disease, severe heart valve failure, pulmonary emboli, severe heart failure, severe infections, musculoskeletal disorders, malignant disease, contraindicated medicine as MAO inhibitors and anticoagulants.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• COPD
• Exercise
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Resistance Training

Intervention

Behavioral:
• Resistance training

• Endurance training

Locations

Country	Name	City	State
Denmark	Centre of Physical Activity Resarch	Copenhagen	Capital Region
Denmark	Centre of Physical Activity Research	Copenhagen	Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle function	Muscle biopsy	At baseline and after 8 weeks of traning	No
Secondary	Flow mediated dilation	Endothelium function	Change from baseline at 8 weeks	No
Secondary	Body composition	DEXA scan	Change from baseline at 8 weeks	No
Secondary	6 min walking test		Change from baseline at 8 weeks	No
Secondary	Health Related Quality of Life - COPD assessment test (CAT)		Change from baseline at 8 weeks	No