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Pulmonary Disease, Chronic ObstructiveNCT03127878

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

A study testing Exercise in people with Pulmonary Disease, Chronic Obstructive, run by Universidade Estadual de Londrina at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 95 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteBrazil
Study dates
12 Jan 2017to 12 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Fabio Pitta, PhD contact

+554333712477

fabiopitta@uol.com.br

Brazil1 site, 1 recruiting
  • State University of Londrina

    Londrina, Paraná, 86038350

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

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the detailed description

Patients with chronic obstructive pulmonary disease (COPD; n=64) will be recruited by convenience and, thereafter, included in this randomized controlled clinical trial. The execution of all the procedures involved in this study will be performed at the Laboratory of Research in Respiratory Physiotherapy (LFIP), located at the University Hospital of the State University of Londrina, Brazil. Prior to starting the exercise training program patients will be evaluated regarding: 1) physical activity in daily life (PADL) by the MoveMonitor (McRoberts, The Netherlands) and by the ActGraph (ActGraph, USA) for seven consecutive days during awake time; 2) lung function by plethysmography; 3) maximum ins- and expiratory pressures (MIP and MEP, respectively) by manovacuometry; 4) body composition by bioelectrical impedance; 5) Performance in activities of daily living (ADL) by the Londrina ADL protocol (LAP), a protocol recently developed at our laboratory, composed by five common activities usually performed by the patients in real life situations; 6) Maximum exercise capacity by the symptom limited maximum test on lower- (increase of 10 watts/minute at a cadence of 50-60 rotations per minute [rpm]) and upper-limbs (5 watts/min at a cadence of 50-60 rpm) performed on cycle ergometer; 7) submaximal exercise capacity (endurance time) for the lower- and upper- limbs at 80% peak work of the respective maximum exercise capacity; 8) functional exercise capacity by the six-minute walk test and the six-minute pegboard and ring test; 9) peripheral muscle strength by the one-repetition maximum test (quantified in kg) of the knee extensors, hip abductors, elbow flexors and extensors, shoulder adductors, and dorsal muscles; and by isometric dynamometry (quantified by kgf) of the quadriceps; 10) Health-related quality of life by the Chronic Respiratory Questionnaire; 11) Health status by the COPD assessment test; 12) functional status by the London Chest Activity of Daily Living scale; 13) symptoms of anxiety and depression by the Hospital Anxiety and Depression scale; 14) and dyspnea sensation in daily life by the Medical Research Council scale. Internationally applied protocols will be followed for all the above-mentioned procedures, and local reference values will be used when appropriated. After the evaluations, patients will be randomly allocated for the traditional exercise-training program (TET) or to TET plus additional upper-limb endurance exercise-training program group (AULET).

After randomization, patients allocated to the TET group will perform lower-limb endurance exercise training on treadmill and on cycle ergometer. For the treadmill, patients will start exercising at 70% of the six-minute walk test average speed and, progressively, the intensity will be increased up to 110% of the six-minute walk test average speed until the last week of the program. For the cycle ergometer, the intensity will start at 60% of the maximum exercise capacity increasing up to 100% until the last week of the program.

For the exercise performed both on treadmill and on cycle, patients will start exercising for 10 minutes, aiming to achieve 20 minutes at the last week. In addition to the pre-schedule intensity-progression, the Borg scale (0 - 10) also will be used as auxiliary tool for guiding the exercise-intensity progression throughout the program. Additionally, patients will perform strengthening exercises for the knee-extensors, hip abductors and adductors, elbow flexors and extensors, shoulder adductors and dorsal muscles. For the strengthening exercises the intensity will start at 60% of the one-repetition maximum test increasing up to 100%. For all muscle groups, strengthening exercises will start with three series of ten repetitions, and progression is intended to achieve three series of 15 repetition by the last week. In addition to the exercises that the TET will be submitted, patients in the AULET will perform additional upper-limb endurance exercises on arm-cycle ergometer, starting at 60% of the maximum exercise capacity, for ten minutes, progressing until 95% of the maximum exercise capacity for 20 minutes in the last week. Borg scale will be used as in the TET to guide exercise-training intensity progression for the upper-limb cycling. In both groups, vital sings (i.e., heart rate, arterial pressure and peripheral oxygen saturation [SPO2]) will be continuously monitored throughout exercise-training sessions. Noteworthy, for those patients developing exercise desaturation (i.e., SPO2 bellow 90% or a drop higher than 4%) oxygen will be offered at a dosage enough to increase peripheral saturation above the desaturation nadir. Patients composing both groups will also receive educational sessions about topics related to disease burden, treatment and self-management.

Being tested
Exercise
Keywords
Exercise, Pulmonary Disease, Chronic Obstructive, Activities of Daily Living, Upper Extremity, Motor Activity
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

Study groups in NCT03127878
Study groupRoleWhat they receive
Active-controlActive comparatorHigh-intensity endurance exercise of lower-limb with strengthening exercise of upper- and lower-limb
Receives: Other: Exercise
Upper-limb additional trainingExperimentalHigh-intensity endurance exercise of upper- and lower-limb with strengthening exercise of upper- and lower-limb
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in active time

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

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

  2. Changes in sedentary time

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

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

  3. 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])

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

Secondary outcomes (19)
  1. Changes in lung function

    Changes in lung flows (l/min) acquired by plethysmography

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

  2. Changes in lung function

    Changes in lung volumes (l) acquired plethysmography

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

  3. Changes in lung function

    Changes in lung capacities (l) acquired plethysmography

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

  4. Changes in respiratory muscle strength

    Change in maximum expiratory pressures (cmH2O) acquired by manovacuometry

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

  5. Changes in respiratory muscle strength

    Change in maximum inspiratory pressures (cmH2O) acquired by manovacuometry

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

  6. Changes in body composition

    Changes in fat-free mass index (kg/m2) acquired by bioelectrical impedance

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

  7. Changes in lower-limb maximum exercise capacity

    Changes in maximum exercise capacity (watts) of the lower-limbs by a symptom limited maximum test on lower-limb ergometer.

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

  8. Changes in upper-limb maximum exercise capacity

    Changes in maximum exercise capacity (watts) of the upper-limbs by a symptom limited maximum test on upper-limb ergometer.

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

  9. Changes in lower-limb submaximal exercise capacity

    Changes in endurance time (seconds) during a constant load test for lower-limb at 80% of maximum exercise capacity on lower-limb ergometer.

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

  10. Changes in upper-limb submaximal exercise capacity

    Changes in endurance time (seconds) during a constant load test for upper-limb at 80% of maximum exercise capacity on upper-limb ergometer.

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

  11. Changes in lower-limb functional exercise capacity

    Changes in the distance walked (meters) by the patients during the Six-minute Walk Test

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

  12. Changes in upper-limb Functional Exercise Capacity

    Changes in the number of rings moved by the patients during the Six-minute pegboard and Ring Test

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

  13. Changes in peripheral muscle strength

    The maximum load (kg) lifted up by the patients during the one-repetition maximum test of upper- and lower-limbs

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

  14. Changes in isometric peripheral muscle strength

    Changes in maximum isometric load (kgf) performed by the patients during the dynamometry of the quadriceps muscle

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

  15. Changes in health-related quality of life

    Changes in healthy-related quality of life score by the Chronic Respiratory Questionnaire

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

  16. Health Status

    Quantification of the healthy status by the COPD Assessment Test score

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

  17. Functional Status

    Quantification of the functional status by the London Chest Activity of Daily Life scale score

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

  18. Change in anxiety and depression

    Changes in anxiety and depression symptoms by the Hospital Anxiety and Depression scale score

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

  19. Changes in dyspnea sensation in daily life

    Changes in the impact of dyspnea in the performance of daily living activities by the Medical Research Council scale score

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start12 Jan 2017
  3. Primary completion12 Jan 2020 (estimated)
  4. Study completion12 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled trial
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127878
Sponsor's protocol ID
070566/2016
Status last verified
Apr 2017
First submitted
11 Apr 2017
Last updated
1 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Pulmonary Disease, Chronic Obstructive, run by Universidade Estadual de Londrina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabio Pitta, PhD (+554333712477, fabiopitta@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in active time (time frame: at the entrance on the study and after at 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.

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