Exercise Training in Severe COPD

March 16, 2022 updated by: Mara Paneroni, Fondazione Salvatore Maugeri

What is the Best Frequency of Exercise Training in Severe COPD?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rehabilitation in-hospital program

The rehabilitation program (RP) will start the day after the in-hospital admission and will be continuously supervised by a physiotherapist. The patients will use the drugs and the oxygen therapy prescribed. RP will include a training session on cycloergometer at constant load once a day (Group F1) or twice-a day (Group F2) interrupted by at least three hours of rest. 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.

Measures

At baseline (T0) we will gather in both groups the following evaluations:

  1. Anthropometric parameters (age, BMI)
  2. Scale of comorbidity CIRS

At the baseline (T0) and end of the program (T1) we will collect, in all patients, the following evaluations:

  1. 6-minute walking test walk (6MWT) will be performed according to international guidelines. In patients using oxygen during walking, the oxygen flow will be adjusted to increase the oxygen saturation over 96%.The 6MWT at T1 will be performed with the same amount of oxygen used in the initial test (T0).
  2. Endurance cycloergometer test will be performed at 80% of Watts max predicted by the 6MWT. At the beginning, the test will be performed at charge "zero watts" for 2 minutes, then the workload will be increased to 80% of the theoretical max Watts until muscle exhaustion (Borg score > 8), presence of high dyspnea (Borg score > 8) or the achievement of 90% of theoretical maximal heart rate. The final endurance test will be repeated at the same load (speed 50-60 rpm). The time spent for performing the exercise will be registered. In a subset of patients (belonging to the Institute of Lumezzane) the endurance cycloergometer test on the quadriceps muscle will be executed by the Near Infrared Spectroscopy (NIRS ).
  3. Scale of the MRC dyspnea
  4. Arterial blood gas analysis
  5. Respiratory muscle strength (Maximal lnspiratory Pressure [MIP] and Maximal Espiratory Pressure [MEP])
  6. Biceps and quadriceps muscle strength evaluated with dynamometer manual
  7. CAT scale

Only at the end of the program (T1) we will collect:

  1. patient satisfaction by a Likert scale taking into consideration the quantity, quality, and impact of rehabilitation on hospitalization
  2. The time consuming for the two programs
  3. The side effect
  4. The drop out (waste, flare)

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • Fondazione Salvatore Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 40 to 80 years
  • Diagnosis of moderate to severe COPD ( GOLD III and IV ) with clinical stability ( pH> 7.38 and no need to change prescription of respiratory drugs in the last 10 days).

Exclusion Criteria:

  • Patients with respiratory failure in absence of COPD
  • Patients who had attended a pulmonary rehabilitation program in the last 6 months
  • Patients with a recent myocardial infarction (in the last 3 months)
  • Patients with congestive heart failure
  • Patients with severe orthopedic diseases
  • Patients with psychiatric illness and severe cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Exercise training F1
Patients will be treated with a specific rehabilitation in-hospital program consisting of one daily sessions of 30 minutes of exercise (Frequency 1 : Program F1 )
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%.
EXPERIMENTAL: Exercise training F2
Patients will be treated with a specific rehabilitation in-hospital program consisting of two daily sessions of 30 minutes of exercise (Frequency 2 : Program F2 )
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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance cycloergometer test: difference between F1 and F2 programs (time needing for the test execution)
Time Frame: 30 days
Evaluation of the time needing for the test execution
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Salvatore Maugeri

Collaborators

Villa Pineta Hospital

Investigators

  • Principal Investigator: Mara Paneroni, PT, Fondazione Salvatore Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2015

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (ESTIMATE)

August 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fondazione Salvatore Maugeri

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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