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

NCT02050945 | Completed DMC

• 1 other identifier: H-2-2013-150
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

COPD; Exercise; Resistance Training

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle function

  Muscle biopsy

  At baseline and after 8 weeks of traning

Secondary Outcomes (4)

• Flow mediated dilation

  Change from baseline at 8 weeks

• Body composition

  Change from baseline at 8 weeks

• 6 min walking test

  Change from baseline at 8 weeks

• Health Related Quality of Life - COPD assessment test (CAT)

  Change from baseline at 8 weeks

Study Arms (2)

Patients with COPD

EXPERIMENTAL

Patients with COPD are to be trained 3 times a week for 8 weeks

Behavioral: Resistance training

Control patients with COPD

ACTIVE COMPARATOR

Control patients with COPD are to be trained 3 times a week for 8 weeks

Behavioral: Endurance training

Interventions

Resistance training BEHAVIORAL

Also known as: Strength training, skeletal muscle, exercise, muscle training

Patients with COPD

Endurance training BEHAVIORAL

Control patients with COPD

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (2)

Centre of Physical Activity Resarch

Copenhagen, Capital Region, 2100, Denmark

Location

Centre of Physical Activity Research

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Resistance Training; Exercise; Endurance Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefan Mortensen, DMSc

  Centre of Inflammation and Metabolism, University of Copenhagen, Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

DK (2)