Different Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)

NCT04201548 | Completed

• 1 other identifier: CE2288
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Chronic Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• 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.

  at baseline, 1 month and 7 months

• 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.

  at baseline and 1 month

• 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).

  at baseline, 1 month and 7 months

Secondary Outcomes (11)

• Percentage of drop out patients

  at 1 month

• Patient's satisfaction: Likert scale

  at 1 month

• Change in dyspnoea

  at baseline, 1 month and 7 months

• Changes in quadriceps volume

  at baseline, 1 month and 7 months

• Change in ADL performance

  at baseline, 1 month and 7 months

Study Arms (3)

Active Comparator

ACTIVE COMPARATOR

This is the constant-load Endurance Training (ET) group which will constitute the control group.

Other: Endurance Training

Long High Intensity Interval Training

EXPERIMENTAL

This is the Long High Intensity Interval Training (Long-HIIT) group.

Other: Long High Intensity Interval Training

Short High Intensity Interval Training

EXPERIMENTAL

This is the Short High Intensity Interval Training (Short-HIIT) group.

Other: Short High Intensity Interval Training

Interventions

Endurance Training OTHER

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

Also known as: ET, Active Comparator

Active Comparator

Long High Intensity Interval Training OTHER

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

Also known as: Long-HIIT, Experimental 1

Long High Intensity Interval Training

Short High Intensity Interval Training OTHER

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

Also known as: Short-HIIT, Experimental 2

Short High Intensity Interval Training

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presence of pulmonary diseases other than COPD
• respiratory tract infections in the last 4 weeks
• termination

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Universita di Verona: collaborator

Study Sites (1)

ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

Location

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mara Paneroni, MSc, PT

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 17, 2019
• Study Start: August 28, 2019
• Primary Completion: June 16, 2023
• Study Completion: June 30, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

IT (1)