Different Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
Primary Purpose
Copd, Chronic Hypoxemic Respiratory Failure
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endurance Training
Long High Intensity Interval Training
Short High Intensity Interval Training
Sponsored by
About this trial
This is an interventional treatment trial for Copd
Eligibility Criteria
Inclusion Criteria:
- age> 50 years
- clinical definition of COPD according to GOLD guidelines (10) with FEV1 / FVC G 70% and FEV1 <50% of the above
- PaO2 in air-ambient lower than 60 mmHg evaluated through arterial blood gas analysis
- oxygen therapy prescription for more than 18 hours/ day for at least one month
- clinical stable condition
Exclusion Criteria:
- presence of pulmonary diseases other than COPD
- respiratory tract infections in the last 4 weeks
- termination
Sites / Locations
- ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of LumezzaneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Active Comparator
Long High Intensity Interval Training
Short High Intensity Interval Training
Arm Description
This is the constant-load Endurance Training (ET) group which will constitute the control group.
This is the Long High Intensity Interval Training (Long-HIIT) group.
This is the Short High Intensity Interval Training (Short-HIIT) group.
Outcomes
Primary Outcome Measures
Changes in effort tolerance
We will evaluate the time to exhaustion (Tlim) of a Constant Load Endurance Test (CLET) taht will be set at load corresponding to 80% of the Watts max achieved at the incremental cicloergometer test.
Changes in the maximal work load
Another way to evaluate changes in effort tolerance will be to evaluate the maximal work load (Watts max) that patients will achive during a cicloergometer incremental test.
Changes in walking distance
Another way to evaluate changes in effort tolerance will be to evaluate meters walked during a 6 minute walking test (6MWT).
Secondary Outcome Measures
Percentage of drop out patients
To evaluate feasibility of the study, we will calculate the percentage of patients dropped out at the end of the rehabilitation period
Patient's satisfaction: Likert scale
To evaluate feasibility of the study, we will administer to patients a questionnaire of satisfaction at the end of the rehabilitation period. Likert scale will be from 0 to 4, where 0= completely unsatisfied and 4= very satisfied)
Change in dyspnoea
We will evaluated dyspnea by Barthel index Dyspnea, a scale measuring dyspnea during basal activities of daily living (ADL). It is a 10-item scale ranging from 0= absence of dyspnea to 100= maximal dyspnea)
Changes in quadriceps volume
We will evaluate changes in muscle volume (quadricips) by ecography
Change in ADL performance
We will evaluate the activities of daily life through the Glittre-ADL test. This consists in a circuit of 5-serie of activities (lifting a chair, walking, lifting 2 steps, moving the weight up and down from a shelf). We will evaluate the total time spent to complete the performance.
Change in fatigue (physiological evaluation)
We will evaluate the change in force generated by a Maximal Volontary Contraction (MVC) and an Electrically stimulated muscular contractions at rest [Resting Twitch (RT)] of the quadriceps muscle (Q) after a fatiguing task ( CLET). Subjects will be seated upright with a back support. The hip and knee will be flexed at 90 ° and the force will be measured by a force transducer.
Electromyographic evaluation: the M waves will be recorded by the Q muscle (vastus lateralis). The EMG signals will be amplified with a bandwidth of 10 Hz-1 kHz and digitized online at a sampling frequency of 5 kHz. Voluntary electromyographic activation of the quadriceps muscle during MVC will be evaluated using a superimposed contraction technique.
Change in fatigue (qualitative evaluation)
For the qualitative evaluation, we will use the Fatigue severity scale that is a 9-item scale ranging from 7= absence of fatigue to 63= maximal presence of fatigue).
Change in Endothelial function
The endothelial function will be evaluated by an ultrasound evaluation of the common femoral artery before and after the application of the short Passive Leg Movement (sPLM) technique.
Change in Balance
To evaluate balance and consequent risk of falls, a Berg scale will be used. Berg scale is composed by 14 balance related tasks, ranging from score 0=worse balance to 56= best balance.
Change in quality of life
COPD Assessment Test (CAT) scale will be used. CAT is a 8-item scale, ranging from score 0 to 40 (where 0=best and 40=worse) evaluating quality of life and well-being
Change in quality of life
MRF scale will be used. MRF is a 28-item questionnaire to assess health outcomes in Chronic Respiratory Failure (CRF). MRF ranges from 26=worse to best = 0
...
Full Information
NCT ID
NCT04201548
First Posted
November 28, 2019
Last Updated
September 27, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT04201548
Brief Title
Different Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
Official Title
Comparison of Clinical and Physiological Response Among Three Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Universita di Verona
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
Advanced Chronic Obstructive Pulmonary Disease (COPD) is a condition with a negative prognosis that causes symptoms such as wheezing and fatigue that dramatically reduce the quality of life of the person with the disease.
Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, causing depression with social isolation, low quality of life and increased risk of death.
Muscle dysfunction in these patients contributes together with dynamic hyperinflation to increased fatigue and dyspnoea during exercise, leading to early interruption of exertion, before reaching the maximal aerobic capacity.
The European and American guidelines of the American Thoracic Society / European Respiratory Society relating to the patient with COPD emphasize the need for the patient to undergo Respiratory Rehabilitation (RR) programs. The RR should include training programs as they improve exercise capacity, dyspnoea and quality of life more than programs that do not include training.
To our knowledge, no study has been performed in COPD with chronic respiratory failure (CRF) patients to evaluate the effects of High Interval Training compared to continuous submaximal training. Moreover, no different interval training protocols have been compared. However, studies conducted on healthy subjects or on other pathologies, show how the interval training protocol induces, in a specific and diversified way, physiological modifications to the cardio-respiratory and muscular systems.
In COPD patients with respiratory failure with marked muscular dysfunction and associated systemic changes (systemic inflammation, vascular changes, pulmonary hypertension, right heart failure, etc.), the evaluation of the best training program would reinforce the rehabilitative indications not yet fully proposed in the Guidelines. Moreover, the evaluation of the response to different training stimuli could provide important information on the reversibility of the intolerance to the effort in this patient population.
Primary aim of this study will be to evaluate the physiological effects on exercise tolerance of three training modalities performed in an intra-hospital setting (classic endurance training compared to two high-intensity interval programs - Long Interval Training and Short Interval training) in a population of COPD patients with chronic hypoxemic respiratory failure.
Detailed Description
Advanced (Chronic Obstructive Pulmonary Disease) COPD is a condition with a negative prognosis that causes symptoms such as wheezing and fatigue that dramatically reduce the quality of life of the person with the disease.
Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, which in turn causes depression and associated social isolation, low quality of life and increased risk of death.
Muscle dysfunction in these patients contributes together with dynamic hyperinflation to increased fatigue and dyspnoea during exercise, leading to early interruption of exertion, before reaching maximum aerobic capacity.
The European and American guidelines of the American Thoracic Society / European Respiratory Society relating to the patient with Chronic Obstructive Pulmonary Disease (COPD) emphasize the need for the patient to undergo Respiratory Rehabilitation (RR) programs. The RR should include training programs as they improve exercise capacity, dyspnoea and quality of life more than programs that do not include training.
However, although there are many studies referring to the benefits of physical exercise in patients with COPD with mild-to-moderate severity, the recent guidelines provide few recommendations for types of training and its efficacy for patients with advanced disease that have already developed Chronic Respiratory Failure (CRF) and use of Long Term Oxygen Therapy (LTOT).
Thanks to a retrospective study on 1047 patients, the Authors have previously shown that patients with COPD with CRF respond to a rehabilitation program (in terms of exercise tolerance, blood gases, dyspnoea and quality of life) as well as COPD patients without CRF.
A recent meta-analysis conducted by Paneroni et al. supports the effectiveness of exercise in improving quality of life and functional capacity in patients with severe COPD (FEV1 <35%), with or without CRF. The study showed that so far the training proposed to these patients is mainly of moderate-intensity endurance and performed primarily through the continuous use of exercise bikes or free walking. In a similar way to patients with moderate or mild severity, the setting of the exercise was mainly proposed using a speed or a load that approximates around 70% of the maximum value reached in an incremental test.
Regarding the type of exercise to be used in patients with COPD, several recent papers suggest the opportunity to use interval training even in high intensity. The purpose of the High Interval Training is to repeatedly stress the cardio-respiratory and muscular system, above "what is normally required for normal activities, through" bouts of high intensity and short duration exercise".
In subjects with COPD, this type of training could guarantee a delay in the development of the dynamic hyperinflation mechanism typical of the pathology and could guarantee greater physiological modifications regarding the classical submaximal continuous training. Despite some physiological studies that have tested this effect, the results of the clinical application of these interventions appear - in subjects with moderate COPD - similar to that got with continuing training. However, the protocols proposed to date appear to be diversified in terms of approach, especially concerning the intensity and duration of the active and passive phases.
To our knowledge, no study has been performed in COPD with CRF patients to evaluate the effects of High Interval Training compared to continuous submaximal training and no protocols on different interval training have been compared. Indeed, studies conducted on healthy subjects or on other pathologies, show how the interval training protocol induces, in a specific and diversified way, physiological modifications to the cardiorespiratory and muscular systems.
In patients with respiratory failure with marked muscular dysfunction and associated systemic changes (systemic inflammation, vascular changes, pulmonary hypertension, right heart failure, etc.), the evaluation of the best training program would reinforce the rehabilitative indications not yet fully proposed in the Guidelines. Moreover, the evaluation of the response to different training stimuli could provide important information on the reversibility of the intolerance to the effort in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Chronic Hypoxemic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
This is the constant-load Endurance Training (ET) group which will constitute the control group.
Arm Title
Long High Intensity Interval Training
Arm Type
Experimental
Arm Description
This is the Long High Intensity Interval Training (Long-HIIT) group.
Arm Title
Short High Intensity Interval Training
Arm Type
Experimental
Arm Description
This is the Short High Intensity Interval Training (Short-HIIT) group.
Intervention Type
Other
Intervention Name(s)
Endurance Training
Other Intervention Name(s)
ET, Active Comparator
Intervention Description
These patients will perform an aerobic exercise with a moderate intensity cycle ergometer. The exercise session on an exercise bike will last 33 minutes at a constant load, starting from an intensity equal to the load of 60% of the maximum load (max watt) achieved at the incremental test.
Working volume = 60 X 33 = 1980
Intervention Type
Other
Intervention Name(s)
Long High Intensity Interval Training
Other Intervention Name(s)
Long-HIIT, Experimental 1
Intervention Description
The patients assigned to the Long-HIIT group will perform a 32-minute interval work with 4x4 protocol (active phase x passive phase) performing 4 minutes at an intensity of 80-85% of the Max Watt (active phase) spaced from 4 minutes to 40% of the Max Watt (passive phase). The goal of high intensity work will be to bring the heart rate to a level close to 85-90% of the maximum cardiac frequency achieved in the incremental exercise test. If this target is not reached within the session, the load of the next one will be increased in the following session with 10 watt steps.
Working volume = 16 X 85 + 16 x 40 = 2000
Intervention Type
Other
Intervention Name(s)
Short High Intensity Interval Training
Other Intervention Name(s)
Short-HIIT, Experimental 2
Intervention Description
The patients assigned to the Short-HIIT group will perform an interval work with initial intensity equal to 100% of the Max Watt highlighted in the incremental exercise stress test in the phase (30 seconds) followed by a passive phase of 30 seconds at 50% of the Max Watt for a period of 26 minutes a day. The intensity will be gradually increased during the sessions with symptom-based progression, according to the protocol of Maltais et al. with steps of 10 watts each increment.
Working volume = 13 X 100 + 13 x 50 = 2050
Primary Outcome Measure Information:
Title
Changes in effort tolerance
Description
We will evaluate the time to exhaustion (Tlim) of a Constant Load Endurance Test (CLET) taht will be set at load corresponding to 80% of the Watts max achieved at the incremental cicloergometer test.
Time Frame
at baseline, 1 month and 7 months
Title
Changes in the maximal work load
Description
Another way to evaluate changes in effort tolerance will be to evaluate the maximal work load (Watts max) that patients will achive during a cicloergometer incremental test.
Time Frame
at baseline and 1 month
Title
Changes in walking distance
Description
Another way to evaluate changes in effort tolerance will be to evaluate meters walked during a 6 minute walking test (6MWT).
Time Frame
at baseline, 1 month and 7 months
Secondary Outcome Measure Information:
Title
Percentage of drop out patients
Description
To evaluate feasibility of the study, we will calculate the percentage of patients dropped out at the end of the rehabilitation period
Time Frame
at 1 month
Title
Patient's satisfaction: Likert scale
Description
To evaluate feasibility of the study, we will administer to patients a questionnaire of satisfaction at the end of the rehabilitation period. Likert scale will be from 0 to 4, where 0= completely unsatisfied and 4= very satisfied)
Time Frame
at 1 month
Title
Change in dyspnoea
Description
We will evaluated dyspnea by Barthel index Dyspnea, a scale measuring dyspnea during basal activities of daily living (ADL). It is a 10-item scale ranging from 0= absence of dyspnea to 100= maximal dyspnea)
Time Frame
at baseline, 1 month and 7 months
Title
Changes in quadriceps volume
Description
We will evaluate changes in muscle volume (quadricips) by ecography
Time Frame
at baseline, 1 month and 7 months
Title
Change in ADL performance
Description
We will evaluate the activities of daily life through the Glittre-ADL test. This consists in a circuit of 5-serie of activities (lifting a chair, walking, lifting 2 steps, moving the weight up and down from a shelf). We will evaluate the total time spent to complete the performance.
Time Frame
at baseline, 1 month and 7 months
Title
Change in fatigue (physiological evaluation)
Description
We will evaluate the change in force generated by a Maximal Volontary Contraction (MVC) and an Electrically stimulated muscular contractions at rest [Resting Twitch (RT)] of the quadriceps muscle (Q) after a fatiguing task ( CLET). Subjects will be seated upright with a back support. The hip and knee will be flexed at 90 ° and the force will be measured by a force transducer.
Electromyographic evaluation: the M waves will be recorded by the Q muscle (vastus lateralis). The EMG signals will be amplified with a bandwidth of 10 Hz-1 kHz and digitized online at a sampling frequency of 5 kHz. Voluntary electromyographic activation of the quadriceps muscle during MVC will be evaluated using a superimposed contraction technique.
Time Frame
at baseline, 1 month and 7 months
Title
Change in fatigue (qualitative evaluation)
Description
For the qualitative evaluation, we will use the Fatigue severity scale that is a 9-item scale ranging from 7= absence of fatigue to 63= maximal presence of fatigue).
Time Frame
at baseline, 1 month and 7 months
Title
Change in Endothelial function
Description
The endothelial function will be evaluated by an ultrasound evaluation of the common femoral artery before and after the application of the short Passive Leg Movement (sPLM) technique.
Time Frame
at baseline, 1 month and 7 months
Title
Change in Balance
Description
To evaluate balance and consequent risk of falls, a Berg scale will be used. Berg scale is composed by 14 balance related tasks, ranging from score 0=worse balance to 56= best balance.
Time Frame
at 1 month and 7 months
Title
Change in quality of life
Description
COPD Assessment Test (CAT) scale will be used. CAT is a 8-item scale, ranging from score 0 to 40 (where 0=best and 40=worse) evaluating quality of life and well-being
Time Frame
1 month and 7 months
Title
Change in quality of life
Description
MRF scale will be used. MRF is a 28-item questionnaire to assess health outcomes in Chronic Respiratory Failure (CRF). MRF ranges from 26=worse to best = 0
...
Time Frame
at 1 month and 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age> 50 years
clinical definition of COPD according to GOLD guidelines (10) with FEV1 / FVC G 70% and FEV1 <50% of the above
PaO2 in air-ambient lower than 60 mmHg evaluated through arterial blood gas analysis
oxygen therapy prescription for more than 18 hours/ day for at least one month
clinical stable condition
Exclusion Criteria:
presence of pulmonary diseases other than COPD
respiratory tract infections in the last 4 weeks
termination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiziana Bachetti, Pharm
Phone
0039+0382+593
Ext
210
Email
tiziana.bachetti@icsmaugeri.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Baiardi, Math
Phone
0039+0382+592
Ext
599
Email
paola.baiardi@icsmaugeri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara Paneroni, MSc, PT
Organizational Affiliation
Istituti Clinici Scientifici Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25065
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara Paneroni, MSc, PT
Phone
0039+030+8253
Ext
167
Email
mara.paneroni@icsmaugeri.it
First Name & Middle Initial & Last Name & Degree
Michele Vitacca, MD
Phone
0039+030+8253
Ext
182
Email
michele.vitacca@icsmaugeri.it
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Different Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
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