Effects of Upper-limb Training Addition to a Conventional ET Program on PA Level and ADL Performance.
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Exercise, Pulmonary Disease, Chronic Obstructive, Activities of Daily Living, Upper Extremity, Motor Activity
Eligibility 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
Sites / Locations
- State University of LondrinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active-control
Upper-limb additional training
Arm Description
High-intensity endurance exercise of lower-limb with strengthening exercise of upper- and lower-limb
High-intensity endurance exercise of upper- and lower-limb with strengthening exercise of upper- and lower-limb
Outcomes
Primary Outcome Measures
Changes in active time
Changes in time spend (in minutes) in daily life in activities above 3 Metabolic Equivalent of Task (METs)
Changes in sedentary time
Changes in time (in minutes) spend in daily life in activities bellow 1.5 METs
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])
Secondary Outcome Measures
Changes in lung function
Changes in lung flows (l/min) acquired by plethysmography
Changes in lung function
Changes in lung volumes (l) acquired plethysmography
Changes in lung function
Changes in lung capacities (l) acquired plethysmography
Changes in respiratory muscle strength
Change in maximum expiratory pressures (cmH2O) acquired by manovacuometry
Changes in respiratory muscle strength
Change in maximum inspiratory pressures (cmH2O) acquired by manovacuometry
Changes in body composition
Changes in fat-free mass index (kg/m2) acquired by bioelectrical impedance
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.
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.
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.
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.
Changes in lower-limb functional exercise capacity
Changes in the distance walked (meters) by the patients during the Six-minute Walk Test
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
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
Changes in isometric peripheral muscle strength
Changes in maximum isometric load (kgf) performed by the patients during the dynamometry of the quadriceps muscle
Changes in health-related quality of life
Changes in healthy-related quality of life score by the Chronic Respiratory Questionnaire
Health Status
Quantification of the healthy status by the COPD Assessment Test score
Functional Status
Quantification of the functional status by the London Chest Activity of Daily Life scale score
Change in anxiety and depression
Changes in anxiety and depression symptoms by the Hospital Anxiety and Depression scale score
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
Full Information
NCT ID
NCT03127878
First Posted
April 11, 2017
Last Updated
April 27, 2017
Sponsor
Universidade Estadual de Londrina
Collaborators
National Council for Scientific and Technological Development (CNPq) - Brazil
1. Study Identification
Unique Protocol Identification Number
NCT03127878
Brief Title
Effects of Upper-limb Training Addition to a Conventional ET Program on PA Level and ADL Performance.
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
January 12, 2020 (Anticipated)
Study Completion Date
January 12, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina
Collaborators
National Council for Scientific and Technological Development (CNPq) - Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Exercise, Pulmonary Disease, Chronic Obstructive, Activities of Daily Living, Upper Extremity, Motor Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active-control
Arm Type
Active Comparator
Arm Description
High-intensity endurance exercise of lower-limb with strengthening exercise of upper- and lower-limb
Arm Title
Upper-limb additional training
Arm Type
Experimental
Arm Description
High-intensity endurance exercise of upper- and lower-limb with strengthening exercise of upper- and lower-limb
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Changes in active time
Description
Changes in time spend (in minutes) in daily life in activities above 3 Metabolic Equivalent of Task (METs)
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in sedentary time
Description
Changes in time (in minutes) spend in daily life in activities bellow 1.5 METs
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in performance in activities of daily living
Description
Changes in time (in seconds) to perform a protocol that is composed by 5 activities of daily living (The Londrina ADL protocol [LAP])
Time Frame
at the entrance on the study and after at 3 months.
Secondary Outcome Measure Information:
Title
Changes in lung function
Description
Changes in lung flows (l/min) acquired by plethysmography
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in lung function
Description
Changes in lung volumes (l) acquired plethysmography
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in lung function
Description
Changes in lung capacities (l) acquired plethysmography
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in respiratory muscle strength
Description
Change in maximum expiratory pressures (cmH2O) acquired by manovacuometry
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in respiratory muscle strength
Description
Change in maximum inspiratory pressures (cmH2O) acquired by manovacuometry
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in body composition
Description
Changes in fat-free mass index (kg/m2) acquired by bioelectrical impedance
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in lower-limb maximum exercise capacity
Description
Changes in maximum exercise capacity (watts) of the lower-limbs by a symptom limited maximum test on lower-limb ergometer.
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in upper-limb maximum exercise capacity
Description
Changes in maximum exercise capacity (watts) of the upper-limbs by a symptom limited maximum test on upper-limb ergometer.
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in lower-limb submaximal exercise capacity
Description
Changes in endurance time (seconds) during a constant load test for lower-limb at 80% of maximum exercise capacity on lower-limb ergometer.
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in upper-limb submaximal exercise capacity
Description
Changes in endurance time (seconds) during a constant load test for upper-limb at 80% of maximum exercise capacity on upper-limb ergometer.
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in lower-limb functional exercise capacity
Description
Changes in the distance walked (meters) by the patients during the Six-minute Walk Test
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in upper-limb Functional Exercise Capacity
Description
Changes in the number of rings moved by the patients during the Six-minute pegboard and Ring Test
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in peripheral muscle strength
Description
The maximum load (kg) lifted up by the patients during the one-repetition maximum test of upper- and lower-limbs
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in isometric peripheral muscle strength
Description
Changes in maximum isometric load (kgf) performed by the patients during the dynamometry of the quadriceps muscle
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in health-related quality of life
Description
Changes in healthy-related quality of life score by the Chronic Respiratory Questionnaire
Time Frame
at the entrance on the study and after at 3 months.
Title
Health Status
Description
Quantification of the healthy status by the COPD Assessment Test score
Time Frame
at the entrance on the study and after at 3 months.
Title
Functional Status
Description
Quantification of the functional status by the London Chest Activity of Daily Life scale score
Time Frame
at the entrance on the study and after at 3 months.
Title
Change in anxiety and depression
Description
Changes in anxiety and depression symptoms by the Hospital Anxiety and Depression scale score
Time Frame
at the entrance on the study and after at 3 months.
Title
Changes in dyspnea sensation in daily life
Description
Changes in the impact of dyspnea in the performance of daily living activities by the Medical Research Council scale score
Time Frame
at the entrance on the study and after at 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Pitta, PhD
Phone
+554333712477
Email
fabiopitta@uol.com.br
Facility Information:
Facility Name
State University of Londrina
City
Londrina
State/Province
Parana
ZIP/Postal Code
86038350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Pitta, PhD
Phone
+554333712477
Email
fabiopitta@uol.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
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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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