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

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

Interventions

OTHER

Endurance Training

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

OTHER

Long High Intensity Interval Training

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

OTHER

Short High Intensity Interval Training

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

Sponsors & Collaborators

• Universita di Verona

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA

  lead OTHER

Principal Investigators

• Mara Paneroni, MSc, PT · Istituti Clinici Scientifici Maugeri

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

51 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-28

Primary Completion

2023-06-16

Completion

2024-06-30

Countries

• Italy

Study Locations