NCT05708443 Effect of Combined Endurance Training on ADL and Walking in COPD Patients
| NCT ID | NCT05708443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-01-10 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-01-10 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load. The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).
Eligibility Criteria
Inclusion Criteria: * GOLD class 2-3 COPD * Forced Expiratory Volume in the first second (FEV1) between 30% and 70% of the predicted value * ability to walk and climb stairs without assistance * stable clinical condition (pH \> 7.35) Exclusion Criteria: * chronic respiratory insufficiency on long-term oxygen therapy (LTOT) * severe orthopedic, neurological or cardiological comorbidities * cognitive impairment * recent exacerbation (within 15 days) requiring a change in therapy * presence of lung disease other than COPD * terminality
Contact & Investigator
Michele Vitacca, MD
STUDY DIRECTOR
ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane
Frequently Asked Questions
Who can join the NCT05708443 clinical trial?
This trial is open to participants of all sexes, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05708443 currently recruiting?
Yes, NCT05708443 is actively recruiting participants. Contact the research team at mara.paneroni@icsmaugeri.it for enrollment information.
Where is the NCT05708443 trial being conducted?
This trial is being conducted at Lumezzane, Italy, Montescano, Italy, Tradate, Italy.
Who is sponsoring the NCT05708443 clinical trial?
NCT05708443 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Michele Vitacca, MD at ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane. The trial plans to enroll 36 participants.
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