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

February 16, 2019 updated by: Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos

Impact of Aerobic and High and Low Resistance Training on Daily Life Activities and BODE Index COPD Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13561-206
        • Special Respiratory Physiotherapy Unit of the Federal University of São Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:Patients both genders, with a clinical diagnosis of COPD confirmed by post bronchodilator spirometry administered by a pneumologist, classified as moderate to very severe obstruction in accordance with the GOLD criteria; ex- or non-smokers; oxygen dependent or not; clinically stable; no history of infection and no exacerbation of respiratory symptoms or changes in medication for at least two months before the study and that no present cardiac, rheumatic or an associated orthopedic disease that prevent them from performing the proposed evaluation tasks.

Exclusion Criteria:Patients who present respiratory, cardiac, rheumatic, musculoskeletal, orthopedic and neuromuscular sequels that may prevent the testing and intervention proposal; that to modify the type of medication during the study; in cases of uncontrolled hypertension or refusal to provide consent proposed in the Resolution of National Council of Health.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low intensity resistance training
Low intensity resistance training + aerobic training
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.
Other Names:
  • LIRT
  • Low-intensity resistance training
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.
Other Names:
  • AT
Experimental: High intensity resistance training
High intensity resistance training + aerobic training
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.
Other Names:
  • AT
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.
Other Names:
  • High-intensity resistance training
  • HIRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxygen Saturation During Activities of Daily Living
Time Frame: Baseline and after 36 sessions, an average of 3 months

TThe ADL performance was assessed by an adapted laboratory circuit of ADL, including: Showering, lifting and lowering containers on a shelf above the shoulder girdle, and raising and lowering pots on a shelf below the pelvic girdle.

Oxygen saturation (SpO2, %) was assessed by pulse oxymeter.
Baseline and after 36 sessions, an average of 3 months
Change in Ventilation During Activities of Daily Living
Time Frame: Baseline and after 36 sessions, an average of 3 months

The ADL performance was assessed by an adapted laboratory circuit of ADL, including: Showering, lifting and lowering containers on a shelf above the shoulder girdle, and raising and lowering pots on a shelf below the pelvic girdle.

Ventilation (VE-l/min) was captured by a portable metabolic system.
Baseline and after 36 sessions, an average of 3 months
Change in Oxygen Consumption During Activities of Daily Living
Time Frame: Baseline and after 36 sessions, an average of 3 months
The ADL performance was assessed by an adapted laboratory circuit of ADL, including: Showering, lifting and lowering containers on a shelf above the shoulder girdle, and raising and lowering pots on a shelf below the pelvic girdle. Gas exchange (oxygen consumption - VO2-l/min) was captured by a portable metabolic system.
Baseline and after 36 sessions, an average of 3 months
Change in Dyspnea Related During Activities of Daily Living
Time Frame: Baseline and after 36 sessions, an average of 3 months
Dyspnea in ADL was assessed by London Chest Activity of Daily Living Scale(LCADL), that consists 15 quantitative questions of 4 domains: self-care, domestic, physical, and leisure. Subjects indicate a score of 0-5, in a total of 75 points. A higher total score indicates greater limitation in performing ADL due to dyspnea.
Baseline and after 36 sessions, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BODE index
Time Frame: Baseline and after 36 sessions, an average of 3 months
In order to calculate the BODE index, the following variables were considered: BMI (body mass index), forced expiratory volume in one second, as the percentage of the predicted value (pred FEV1 %), mMRC score (modified Medical Research Council Scale) and in the 6MWD (Six-Minute Walk Distance). The score was considered according to the results obtained from the four variables (0-3 for FEV1; 0-3 for mMRC; 0-3 for 6MWD and 0-1 for BMI), and total score ranged from 0 to 10 (higher scores indicate more severity).
Baseline and after 36 sessions, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Director: Valéria Amorim Pires Di Lorenzo, PhD, Universidade Federal de Sao Carlos
  • Principal Investigator: Júlia Gianjoppe dos Santos, PhD, Universidade Federal de Sao Carlos
  • Principal Investigator: Marina Sallum Barusso, MsC, Universidade Federal de Sao Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EditalUniversal2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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