Effects of Upper-limb Training Addition to a Conventional ET Program on PA Level and ADL Performance.

NCT03127878 | Unknown

• 1 other identifier: 070566/2016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite recent recommendations for the inclusion of upper-limb endurance training in exercise training programs (ET) for patients with COPD, the majority of theses programs are yet focused only in lower-limb endurance training. However, these patients may have a hindered performance during the execution of simple activities of daily living (ADL) involving the upper-limbs. Therefore, one doubt remains: is the addition of upper-limb endurance training necessary? Aims: To verify whether patients with COPD become more physically active in daily life, as well as whether they improve ADL performance after two protocols of ET: 1) traditional ET (TET; endurance exercises of the lower-limbs and strengthening exercise for upper- and lower-limbs) and 2) TET + additional upper-limb endurance exercise (AULET). Methods: Patients with COPD (n= 64) will be included in this randomized controlled clinical trial. Before randomization to TET or AULET patients will be evaluated regarding physical activity in daily life (PADL; accelerometers), lung function (plethysmography), respiratory muscle strength (maximum ins- and expiratory pressures), body composition (bioelectrical impedance), performance in ADL (Londrina ADL protocol), maximum exercise capacity (symptom limited maximum test of lower and upper limbs), submaximal exercise capacity (endurance time at 80% of the maximum upper- and lower-limb capacity), functional exercise capacity (six-minute walk test and six-minute pegboard and ring test), peripheral muscle strength (one-repetition maximum test and dynamometry), healthy-related quality of life (Chronic Respiratory Questionnaire), health status (COPD assessment test), functional status (London Chest Activity of Daily Life scale) and symptoms of anxiety and depression (Hospital Anxiety and Depression Scale). Patients in both groups will exercise three times per week for 12 weeks. TET will be composed by endurance exercise for the lower-limbs (walking on treadmill and lower-limb cycling) plus strengthening exercises for upper- and lower limbs. Group AULET will perform the same exercises plus the additional upper-limb endurance training (upper-limb "cycling"). Patients will be evaluated by the same procedures after the ET. Hypothesis: The addition of upper-limb endurance training will increase PADL and ADL performance to a greater extent than the traditional exercise-training program alone due to greater reduction of physical activity-related dyspnea.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Exercise; Pulmonary Disease, Chronic Obstructive; Activities of Daily Living; Upper Extremity; Motor Activity

Outcome Measures

Primary Outcomes (3)

• Changes in active time

  Changes in time spend (in minutes) in daily life in activities above 3 Metabolic Equivalent of Task (METs)

  at the entrance on the study and after at 3 months.

• Changes in sedentary time

  Changes in time (in minutes) spend in daily life in activities bellow 1.5 METs

  at the entrance on the study and after at 3 months.

• Changes in performance in activities of daily living

  Changes in time (in seconds) to perform a protocol that is composed by 5 activities of daily living (The Londrina ADL protocol \[LAP\])

  at the entrance on the study and after at 3 months.

Secondary Outcomes (19)

• Changes in lung function

  at the entrance on the study and after at 3 months.

• Changes in lung function

  at the entrance on the study and after at 3 months.

• Changes in lung function

  at the entrance on the study and after at 3 months.

• Changes in respiratory muscle strength

  at the entrance on the study and after at 3 months.

• Changes in respiratory muscle strength

  at the entrance on the study and after at 3 months.

Study Arms (2)

Active-control

ACTIVE COMPARATOR

High-intensity endurance exercise of lower-limb with strengthening exercise of upper- and lower-limb

Other: Exercise

Upper-limb additional training

EXPERIMENTAL

High-intensity endurance exercise of upper- and lower-limb with strengthening exercise of upper- and lower-limb

Other: Exercise

Interventions

Exercise OTHER

Active-control; Upper-limb additional training

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnose of chronic obstructive pulmonary disease according to the Global Initiative for chronic obstructive lung disease
• Absence of exacerbation in the previous month (clinical stability)
• Absence of severe or non-stable cardiac disease
• Absence of conditions able to impair the execution of the tests or the proposed treatment
• Do not be part of any exercise training program in the previous year

You may not qualify if:

• Severe exacerbation of the disease needing long-term hospitalisation
• Development of others conditions or diseases able to interfere in the proposed treatment or its results

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

State University of Londrina

Londrina, Paraná, 86038350, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Fabio Pitta, PhD

CONTACT

+554333712477; fabiopitta@uol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 25, 2017
• Study Start: January 12, 2017
• Primary Completion: January 12, 2020
• Study Completion: January 12, 2020
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)