NCT01529489

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) present slowed pulmonary oxygen uptake (VO2) and heart rate (HR) kinetics compared with age-matched controls. Patients with COPD present significant loss of body mass, decreased strength and endurance of respiratory muscles and lower limbs, leading reduced exercise capacity. This reduced exercise capacity can be marked by slowed kinetics of VO2 and HR at the onset of heavy-intensity exercise. Additionally, derangements in the diffusive and convective transport of oxygen to skeletal muscle mitocondria, and intramyocyte metabolic machinery, higher ventilation and disturbances in mechanics of breathing, hypoxemia, pulmonary hemodynamics, autonomic balance, and peripheral vasodilation, and accumulation of by-products that might be related to increased muscle fatigability could slow the response of systemic (central) and peripheral (microvascular) oxygen delivery to a point where the kinetics of VO2 might become limited by O2 availability and HR. Thus, the physical training programs of the lower limbs, in addition to presenting scientific evidence "A", are important components, resulting in the reversal of the manifestations of COPD, resulting in improvement in exercise capacity, well significantly speeded VO2 and HR kinetics in patients with COPD. However, it should be taken into account the choice of an appropriate program limitations and severity of disease. Assuming that COPD patients present slower VO2 and HR kinetics, the investigators hypothesized that the heavy-intense interval physical training in equipament elliptical would promote a greater increase in the functionality (functional performance) and speeded kinetics in the cycle ergometer and elliptical equipment constant-load intense exercises tests of COPD patients. In this context, the present study intends to evaluate and compare the effects of resistive plus aerobic physical training and interval physical training on oxygen consumption (VO2) and heart rate (HR) kinetics responses at the onset in cycle ergometer and elliptical equipment constant-load intense exercises tests in patients with COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

2.9 years

First QC Date

February 2, 2012

Last Update Submit

February 6, 2012

Conditions

Keywords

Chronic Obstructive Pulmonary DiseasePhysical trainingOxygen uptake kineticHeart rate kinetic

Outcome Measures

Primary Outcomes (1)

  • Effect of aerobic and resisted physical training and interval physical training on oxygen uptake and heart rate on-kinetics in patients with COPD.

    The kinetic analysis was measured before and after interval physical training and aerobic and resisted physical training by Cardiopulmonary Exercise Testing (CPT; Incremental symptom-limited exercise testing), Constant-load exercise test in cycle ergometer and Constant-load exercise test in elliptical equipament. The on-transient (first 180 seconds) response of VO2 and HR was modeled according to a monoexponencial fit.

    baseline and 6 weeks

Secondary Outcomes (8)

  • Change in oxygen consumption, minute ventilation, ventilatory limitation, pulmonary carbon dioxide output, metabolic rate.

    baseline and 6 weeks

  • Change in oxygenation

    baseline and 6 weeks

  • Change in heart rate and heart rate reserve

    baseline and 6 weeks

  • Change in dyspnea and perceived discomfort in lower limbs

    baseline and 6 weeks

  • Change in quality of life and Daily Life Activities

    baseline and 6 weeks

  • +3 more secondary outcomes

Study Arms (4)

Interval physical training Control group

ACTIVE COMPARATOR
Other: Interval physical training in elliptical equipament

Resisted/Aerobic physical training group

EXPERIMENTAL
Other: Resisted/Aerobic physical training

Aerobic/resisted physical training group

ACTIVE COMPARATOR
Other: Resisted/Aerobic physical training

Interval physical training group

EXPERIMENTAL

COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic

Other: Interval physical training in elliptical equipament

Interventions

COPD, aerobic physical training in cicloergometer, resisted physical training in cicloergometer, oxygen uptake kinetic, heart rate kinetic.

Also known as: COPD,, aerobic physical training in cicloergometer,, resisted physical training in cicloergometer,, oxygen uptake kinetic,, heart rate kinetic.
Resisted/Aerobic physical training group

Control group (healthy individuals), interval physical training, elliptical equipment, oxygen uptake kinetic, heart rate kinetic.

Also known as: Control group (healthy individuals),, interval physical training in elliptical equipment,, oxygen uptake kinetic,, heart rate kinetic.
Interval physical training Control group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experimental Group:
  • Patients with clinical and spyrometric diagnosis of COPD presenting FEV1/FVC \< 70% and FEV1 \< 80% predicted by pulmonary function observed and were classified as patients with moderate to very severe obstruction (GOLD, 2010).
  • Clinically stable with no history infection or exacerbation of the respiratory symptoms or change in medication for two months preceding the study.
  • Patients were non oxygen dependent, smokers or former smokers.
  • No subject in the COPD group had ever participated in a pulmonary rehabilitation program (i.e., sedentary during the year preceding admission to the study).
  • Adherence to the individually prescribed treatment regimen.
  • Control Group:
  • Pulmonary Function normal.
  • Subjects in the control group were free of chronic pulmonary, cardiovascular, immune, and metabolic disease.
  • Healthy controls who were sedentary during the year preceding admission to the study.

You may not qualify if:

  • Patients with clinical diagnosis of COPD presenting FEV1/FVC ≥ 70% FEV1 ≥ 80% predicted (GOLD, 2010).
  • Malignancy, orthopedic or neurological conditions affecting the ability to exercise, peripheral arterial disease, clinically apparent heart failure, and/or any renal, hepatic or inflammatory disease.
  • Changed the type of medication during the study.
  • Uncontrolled hypertension patients.
  • Peripheral oxygen saturation below 90% at rest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of sao Carlos

SĂ£o Carlos, SĂ£o Paulo, 13565-905, Brazil

Location

Related Publications (37)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Bruna V Pessoa, Ms

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 8, 2012

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations