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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low intensity resistance training
High intensity resistance training
Aerobic training
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Activities of Daily Living, Mortality, Strength Training

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Special Respiratory Physiotherapy Unit of the Federal University of São Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low intensity resistance training

High intensity resistance training

Arm Description

Low intensity resistance training + aerobic training

High intensity resistance training + aerobic training

Outcomes

Primary Outcome Measures

Change in Oxygen Saturation During Activities of Daily Living
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.
Change in Ventilation During Activities of Daily Living
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.
Change in Oxygen Consumption During Activities of Daily Living
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.
Change in Dyspnea Related During Activities of Daily Living
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.

Secondary Outcome Measures

Change in BODE index
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).

Full Information

First Posted
September 20, 2013
Last Updated
February 16, 2019
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01977469
Brief Title
Randomized Controlled Study to Investigate the Impact of Different Intensities Training on ADL and BODE Index in COPD
Official Title
Impact of Aerobic and High and Low Resistance Training on Daily Life Activities and BODE Index COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Activities of Daily Living, Mortality, Strength Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low intensity resistance training
Arm Type
Experimental
Arm Description
Low intensity resistance training + aerobic training
Arm Title
High intensity resistance training
Arm Type
Experimental
Arm Description
High intensity resistance training + aerobic training
Intervention Type
Behavioral
Intervention Name(s)
Low intensity resistance training
Other Intervention Name(s)
LIRT, Low-intensity resistance training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High intensity resistance training
Other Intervention Name(s)
HIRT, High-intensity resistance training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic training
Other Intervention Name(s)
AT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Oxygen Saturation During Activities of Daily Living
Description
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.
Time Frame
Baseline and after 36 sessions, an average of 3 months
Title
Change in Ventilation During Activities of Daily Living
Description
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.
Time Frame
Baseline and after 36 sessions, an average of 3 months
Title
Change in Oxygen Consumption During Activities of Daily Living
Description
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.
Time Frame
Baseline and after 36 sessions, an average of 3 months
Title
Change in Dyspnea Related During Activities of Daily Living
Description
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.
Time Frame
Baseline and after 36 sessions, an average of 3 months
Secondary Outcome Measure Information:
Title
Change in BODE index
Description
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).
Time Frame
Baseline and after 36 sessions, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valéria Amorim Pires Di Lorenzo, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Júlia Gianjoppe dos Santos, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Sallum Barusso, MsC
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Special Respiratory Physiotherapy Unit of the Federal University of São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13561-206
Country
Brazil

12. IPD Sharing Statement

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derived

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

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