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

NCT01977469 | Completed

• 1 other identifier: EditalUniversal2011
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Activities of Daily Living; Mortality; Strength Training

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and after 36 sessions, an average of 3 months

• 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.

  Baseline and after 36 sessions, an average of 3 months

• 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.

  Baseline and after 36 sessions, an average of 3 months

• 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.

  Baseline and after 36 sessions, an average of 3 months

Secondary Outcomes (1)

• Change in BODE index

  Baseline and after 36 sessions, an average of 3 months

Study Arms (2)

Low intensity resistance training

EXPERIMENTAL

Low intensity resistance training + aerobic training

Behavioral: Low intensity resistance training; Behavioral: Aerobic training

High intensity resistance training

EXPERIMENTAL

High intensity resistance training + aerobic training

Behavioral: High intensity resistance training; Behavioral: Aerobic training

Interventions

Low intensity resistance training BEHAVIORAL

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.

Also known as: LIRT, Low-intensity resistance training

Low intensity resistance training

High intensity resistance training BEHAVIORAL

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.

Also known as: HIRT, High-intensity resistance training

High intensity resistance training

Aerobic training BEHAVIORAL

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.

Also known as: AT

High intensity resistance training; Low intensity resistance training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Special Respiratory Physiotherapy Unit of the Federal University of São Carlos

São Carlos, São Paulo, 13561-206, Brazil

Location

Related Publications (16)

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• Barusso MS, Gianjoppe-Santos J, Basso-Vanelli RP, Regueiro EM, Panin JC, Di Lorenzo VA. Limitation of Activities of Daily Living and Quality of Life Based on COPD Combined Classification. Respir Care. 2015 Mar;60(3):388-98. doi: 10.4187/respcare.03202. Epub 2014 Dec 9.

  PMID: 25492955 DERIVED

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

Study Officials

• Valéria Amorim Pires Di Lorenzo, PhD

  Universidade Federal de Sao Carlos

  STUDY DIRECTOR

• Júlia Gianjoppe dos Santos, PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

• Marina Sallum Barusso, MsC

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: November 6, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

BR (1)