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

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ClinicalTrials.gov Identifier: NCT03127878
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : May 1, 2017
Sponsor:
Collaborator:
National Council for Scientific and Technological Development (CNPq) - Brazil
Information provided by (Responsible Party):
Fabio Pitta, PhD, Universidade Estadual de Londrina

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Upper-limb Endurance Exercise Training Addition to a Conventional High-intensity Exercise Training Program on Physical Activity Level and Activities of Daily Living Performance in Patients With COPD
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : January 12, 2020
Estimated Study Completion Date : January 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active-control
High-intensity endurance exercise of lower-limb with strengthening exercise of upper- and lower-limb
Other: Exercise
Experimental: Upper-limb additional training
High-intensity endurance exercise of upper- and lower-limb with strengthening exercise of upper- and lower-limb
Other: Exercise



Primary Outcome Measures :
  1. Changes in active time [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in time spend (in minutes) in daily life in activities above 3 Metabolic Equivalent of Task (METs)

  2. Changes in sedentary time [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in time (in minutes) spend in daily life in activities bellow 1.5 METs

  3. Changes in performance in activities of daily living [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in time (in seconds) to perform a protocol that is composed by 5 activities of daily living (The Londrina ADL protocol [LAP])


Secondary Outcome Measures :
  1. Changes in lung function [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in lung flows (l/min) acquired by plethysmography

  2. Changes in lung function [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in lung volumes (l) acquired plethysmography

  3. Changes in lung function [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in lung capacities (l) acquired plethysmography

  4. Changes in respiratory muscle strength [ Time Frame: at the entrance on the study and after at 3 months. ]
    Change in maximum expiratory pressures (cmH2O) acquired by manovacuometry

  5. Changes in respiratory muscle strength [ Time Frame: at the entrance on the study and after at 3 months. ]
    Change in maximum inspiratory pressures (cmH2O) acquired by manovacuometry

  6. Changes in body composition [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in fat-free mass index (kg/m2) acquired by bioelectrical impedance

  7. Changes in lower-limb maximum exercise capacity [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in maximum exercise capacity (watts) of the lower-limbs by a symptom limited maximum test on lower-limb ergometer.

  8. Changes in upper-limb maximum exercise capacity [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in maximum exercise capacity (watts) of the upper-limbs by a symptom limited maximum test on upper-limb ergometer.

  9. Changes in lower-limb submaximal exercise capacity [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in endurance time (seconds) during a constant load test for lower-limb at 80% of maximum exercise capacity on lower-limb ergometer.

  10. Changes in upper-limb submaximal exercise capacity [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in endurance time (seconds) during a constant load test for upper-limb at 80% of maximum exercise capacity on upper-limb ergometer.

  11. Changes in lower-limb functional exercise capacity [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in the distance walked (meters) by the patients during the Six-minute Walk Test

  12. Changes in upper-limb Functional Exercise Capacity [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in the number of rings moved by the patients during the Six-minute pegboard and Ring Test

  13. Changes in peripheral muscle strength [ Time Frame: at the entrance on the study and after at 3 months. ]
    The maximum load (kg) lifted up by the patients during the one-repetition maximum test of upper- and lower-limbs

  14. Changes in isometric peripheral muscle strength [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in maximum isometric load (kgf) performed by the patients during the dynamometry of the quadriceps muscle

  15. Changes in health-related quality of life [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in healthy-related quality of life score by the Chronic Respiratory Questionnaire

  16. Health Status [ Time Frame: at the entrance on the study and after at 3 months. ]
    Quantification of the healthy status by the COPD Assessment Test score

  17. Functional Status [ Time Frame: at the entrance on the study and after at 3 months. ]
    Quantification of the functional status by the London Chest Activity of Daily Life scale score

  18. Change in anxiety and depression [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in anxiety and depression symptoms by the Hospital Anxiety and Depression scale score

  19. Changes in dyspnea sensation in daily life [ Time Frame: at the entrance on the study and after at 3 months. ]
    Changes in the impact of dyspnea in the performance of daily living activities by the Medical Research Council scale score



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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127878


Contacts
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Contact: Fabio Pitta, PhD +554333712477 fabiopitta@uol.com.br

Locations
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Brazil
State University of Londrina Recruiting
Londrina, Parana, Brazil, 86038350
Contact: Fabio Pitta, PhD    +554333712477    fabiopitta@uol.com.br   
Sponsors and Collaborators
Universidade Estadual de Londrina
National Council for Scientific and Technological Development (CNPq) - Brazil

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Responsible Party: Fabio Pitta, PhD, Professor, PhD, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT03127878     History of Changes
Other Study ID Numbers: 070566/2016
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fabio Pitta, PhD, Universidade Estadual de Londrina:
Exercise
Pulmonary Disease, Chronic Obstructive
Activities of Daily Living
Upper Extremity
Motor Activity

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive