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Exercise Training in Severe COPD

NCT02522637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-03-31

No results posted yet for this study

Summary

International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate COPD patients looking at the work setting, programs and frequency of training sessions in an outpatient program of rehabilitation. However, a new population of respiratory patients is growing: these are more serious and older patients, with several comorbidities and recurrent hospitalizations. In this population no guidelines are available to describe the optimum prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In this kind of patients, only few studies are available on the overtraining risk. The aims of the current study are:

1. To detect and compare the response in terms of endurance of two endurance training programs with different time-frequencies (1 session / day versus 2 sessions / day) during 30 days of in-hospital admission to a pulmonary rehabilitation center
2. To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and respiratory muscle strength, quality of life and psychological and functional impact of the disease.

Conditions

Interventions

OTHER

Exercise training

The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al. Each training session will begin with three minutes of warm-up and cool-down with a low load. At the end of each session, the physiotherapist will administer the Borg Scale (i.e. for dyspnea and muscle fatigue) and detect the oxygen saturation. The sessions will be conducted at constant load for 25 minutes and increase following the Maltais protocol (the workload increase in the next session will be 10 W, if dyspnea and muscle fatigue, evaluated at the Borg Scale, were each \< 5 ). The patients will perform a supervised 20-min light warm-up gym exercise before the endurance training session. The training will be carried out with the oxygen level necessary to maintain the saturation level ≥ 91%.

Sponsors & Collaborators

  • Villa Pineta Hospital

    collaborator OTHER

  • Fondazione Salvatore Maugeri

    lead OTHER

Principal Investigators

  • Mara Paneroni, PT · Fondazione Salvatore Maugeri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-12-31
Completion
2018-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522637 on ClinicalTrials.gov