Physical Training and Heart Rate Variability in COPD

NCT01889563 | Completed Results

• 1 other identifier: COPD6VS12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To contrast the potential effects of physical exercise training program (PTP) of a 6 versus 12 weeks on cardiac autonomic modulation by linear and non-linear heart rate variability (HRV) indices and functional capacity in moderate-to-severe COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease; heart rate variability; physical training

Outcome Measures

Primary Outcomes (1)

• The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.

  Patients underwent the assessments proposed in the study on an outpatient basis before and after 6 and 12 weeks of physical exercise training program. The primary end-point measure was the SD1, a nonlinear index of HRV that represent the parasympathetic modulation

  baseline (before physical exercise training program), 6 and 12 weeks after intervention

Secondary Outcomes (1)

• Walking Distance on Six Minute Walking Test

  Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program

Study Arms (2)

Physical exercise training program

EXPERIMENTAL

Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.

Other: Physical Exercise Training Program Exercise

No Physical Exercise Training Program

NO INTERVENTION

No Physical Exercise Training Program

Interventions

Physical Exercise Training Program Exercise OTHER

Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.

Physical exercise training program

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of COPD according to criteria set forth by the Global Initiative for Chronic Obstructive Lung Disease (19),
• compliance with medical management,
• no change in medical management and no decompensation episodes for at least one month prior to study initiation, and
• no participation in a regular physical exercise program for at least six months prior to study initiation.

You may not qualify if:

• presence of orthopedic or neurological conditions that would preclude participation in a physical exercise program,
• a history of cardiac arrhythmias,
• a past history consistent with heart disease, diabetes mellitus, arterial hypertension and failure to comply with the research protocol.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal university f Sao Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Audrey Borghi e Silva
• Organization: Federal university of Sao Carlos

audrey@ufscar.br

+55 163351-8952

Study Officials

• Audrey Borghi-Silva, PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 28, 2013
• Study Start: May 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2013
• Last Updated: January 10, 2014
• Results First Posted: January 10, 2014

Record last verified: 2013-11

Locations

BR (1)