NCT04201548Completed
Different Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
Comparison of Clinical and Physiological Response Among Three Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
Source: ClinicalTrials.gov · Last updated 31 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 28 Nov 2019
- Start date
- 28 Aug 2019
- Primary completion date
- 16 Jun 2023
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- COPD
- NCT number
- NCT04201548
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 28 Aug 2019 to the primary completion date, 16 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- presence of pulmonary diseases other than COPD
- respiratory tract infections in the last 4 weeks
Other
- termination
Who the study is looking for
- 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
Age in the registry: 51 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane Coordinator of this site? Confirm its status | Lumezzane | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.