Randomized Controlled Study to Investigate the Impact of Different Intensities Training on ADL and BODE Index in COPD

NCT01977469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-02-19

No results posted yet for this study

Summary

The local and systemic manifestations that affect patients with Chronic Obstructive Pulmonary Disease (COPD) cause severe dyspnoea and limitation of functional capacity, leading to impairment in the performance of activities of daily living (ADL). The combination of aerobic and resistance training, for both upper limbs (UL) and lower limbs (LL), appears to be the physiologically most complete resource for improving quality of life and increased survival of these patients. Therefore, the aim of the study is to assess the impact of aerobic and resistance training of different intensities on the performance and dyspnoea during activities of daily living and prediction of mortality in patients with COPD. There will be include 45 COPD patients with moderate to severe obstruction, aged between 50-80 years of both gender. All patients will undergo to the following assessments and reassessments: history and anthropometric data, Scale London Chest Activity of Daily Living Scale (LCADL), modified Medical Research Council (mMRC), BODE index, test peripheral muscle strength, mobility and balance tests, 6-minute walk test (6MWT), Circuit ADL Test, 1 repetition maximum (1RM) and Incremental Cardiopulmonary Testing (ICPT). Patients will be randomly divided into two groups and undergo to the treatment program will consist of sessions lasting approximately 1 hour, three times a week for 12 consecutive weeks, totaling 36 sessions. All patients will undergo general stretching and aerobic training on a cycle ergometer with the intensity between 70-80 % of the maximum load achieved in ICPT. After aerobic training, a group of patients will achieve a protocol of low-intensity resistance training (LI-RT), with emphasis on gaining muscle strength, and the other group will be submitted to a protocol of high intensity (HI-RT), aiming greater gain in muscle strength. The calculation of the intensity of training will be conducted by the 1RM test. After the training protocol, it is expected to find improved performance and dyspnoea during activities of daily living and reduction of BODE index for both groups, however, it is expected that the group of low-intensity resistance training presents greater benefits in ADL.

Conditions

Interventions

BEHAVIORAL

Low intensity resistance training

The LIRT group initiated the resistance training for UL with 30% of the 1RM, with 5% increases each nine sessions; therefore, the maximum load was 45% of the 1RM. The LL training initiated with 30% of the 1RM, increasing 7% each nine sessions, thus, the maximum load was 51% of the 1RM. Each exercise session consisted of three sets of 15 repetitions, with a 2 minutes interval between sets.

BEHAVIORAL

High intensity resistance training

the initial load for HIRT group was 60% of 1RM for UL with 5% increases each nine sessions; therefore, the maximum load reached 75% of the 1RM. The LL training initiated with 60% of the 1RM with 7% increments each nine sessions, as a result, the maximum load after 36 sessions was 81% of the 1RM. These patients underwent three sets of eight repetitions, with two minutes intervals between sets.

BEHAVIORAL

Aerobic training

Patients underwent an aerobic training in cycle ergometer, with load intensity determined as the same load the patient presented a VO2 value of 70-80% of the peak VO2 obtained in the symptom-limited CPET. Each session of aerobic training lasted 20-30min according to patient's tolerance.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • Universidade Federal de Sao Carlos

    lead OTHER

Principal Investigators

  • Valéria Amorim Pires Di Lorenzo, PhD · Universidade Federal de Sao Carlos

  • Júlia Gianjoppe dos Santos, PhD · Universidade Federal de Sao Carlos

  • Marina Sallum Barusso, MsC · Universidade Federal de Sao Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977469 on ClinicalTrials.gov