The Effect of Two Weeks of Voluntary Reduced Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

NCT02221804 | Unknown DMC

• 1 other identifier: 2014LF002B
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is the most common pulmonary disease, responsible for considerable morbidity and mortality and is the third leading cause of death worldwide. As well as its consequences in the lungs, COPD is well recognized to be associated with a range of important systemic consequences and co-morbidities. Interestingly, skeletal muscle dysfunction is noted in both early and advanced disease, suggesting its origins may not be wholly pulmonary. Treatment strategies targeting lung function are, unfortunately, of limited value. Given the burden of disease, it is becoming increasingly important that investigative and therapeutic work now focuses on other systemic characteristics and sequelae which define the disease phenotype. This is a randomized controlled trial of the effect of 14 days of voluntary reduced activity on muscle mass, muscle strength, body composition, and atrophy signalling in patients with COPD and age-matched controls. The primary hypothesis upon which this study is based is that a short reduction in ambulation will induce a transient reduction in quadriceps muscle mass, quadriceps strength and physical performance in patients with COPD compared to matched COPD patients whose mobility has not been restricted. The secondary hypothesis is that the magnitude of the above changes will be greater in physically inactive COPD patients compared to physically inactive age-matched controls. The overall aim of this research is to use an in vivo human model of 14 days of voluntary reduced physical activity to test the above hypotheses. If the model proves feasible, this will allow for earlier proof of concept studies of novel therapeutic agents.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Muscle Atrophy

Keywords

Physical Inactivity; Skeletal Muscle; Cachexia

Outcome Measures

Primary Outcomes (1)

• Quadriceps muscle mass as measured by dual-energy x-ray absorptiometry (DEXA) after two weeks of voluntary reduced physical activity.

  Dual-energy X-ray absorptiometry (DEXA) scanning will be used to assess body composition. Two X-ray beams with different energy levels are used during this technique. It is a widely used scanning modality and is entirely painless. The radiation received by the patient during the scan is less than that of an airline flight from California to New York and back. Specifically, appendicular lean composition will be measured (g).

  Change from baseline in quadriceps muscle mass at 14 days.

Secondary Outcomes (6)

• Quadriceps strength determined as maximal voluntary contraction force (QMVC) and the force elicited by unpotentiated supramaximal stimulation of the femoral nerve (TwQ).

  Before and after the 14 day intervention

• Rectus Femoris Cross Sectional Area determined by Quadriceps Ultrasound (RFCSA US)

  Before and after the 14 day intervention

• 6 minute walk distance (6MWD)

  Before and after the 14 day intervention

• Short Physical Performance Battery (SPPB)

  Before and after the 14 day intervention

• Blood and urinary biomarkers

  Before and after the 14 day intervention

Study Arms (3)

COPD - reduced activity levels

EXPERIMENTAL

COPD patients who have voluntarily decreased their daily physical activity levels to no more than 1500 steps/day for 14 days.

Behavioral: 14 days of voluntary step count reduction to no more than 1500 steps/day.

Healthy - reduced activity levels

EXPERIMENTAL

Healthy age-matched controls who have voluntarily decreased their daily physical activity levels to no more than 1500 steps/day for 14 days.

Behavioral: 14 days of voluntary step count reduction to no more than 1500 steps/day.

COPD - unchanged activity levels

NO INTERVENTION

Interventions

14 days of voluntary step count reduction to no more than 1500 steps/day. BEHAVIORAL

COPD - reduced activity levels; Healthy - reduced activity levels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking adult patients with COPD (GOLD stage II-IV)
• Non-smoking, healthy, age-matched controls
• Baseline step count \> 3500 steps/day
• Baseline 6 minute walk distance \> 140m

You may not qualify if:

• Inability to provide written, informed consent
• Significant co-morbidity limiting exercise tolerance
• Within 1 month of acute exacerbation of COPD
• Within 1 month of pulmonary rehabilitation
• History of venous thrombo-embolism or known increased risk of thrombotic disease

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscular Atrophy; Sedentary Behavior; Cachexia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior; Weight Loss; Body Weight Changes; Body Weight; Thinness

Study Officials

• Michael Polkey, FRCP PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Kladidis, MB BS MRCP

CONTACT

02073518029; s.kladidis@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

GB (1)