Effect of Combined Endurance Training on ADL and Walking in COPD Patients

May 29, 2025 updated by: Istituti Clinici Scientifici Maugeri SpA

Effect of Combined Upper and Lower Extremity Endurance Training Versus Lower Extremity Training Alone on ADL and Walking in COPD Patients

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

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). COPD patients often rely on a caregiver to perform some ADLs for intolerable dyspnea and fatigue since the early stages of the disease. In fact, even while performing simple ADLs, COPD patients develop dynamic hyperinflation and reach a ventilatory limit that forces them to stop or slow down. Symptoms and disability worsen the patient's quality of life.

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.

Lower extremity cycle ergometer training improves peak oxygen uptake, and reduces heart rate, minute ventilation, dyspnea, and leg fatigue at submaximal work speeds. Moreover, upper limb training has been described to reduce dyspnea, increase respiratory muscle strength, and have an effect on patients' global exercise tolerance.

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.

To our knowledge, no study has investigated training programs in COPD patients with similar timing of intervention comparing selective lower extremity endurance training with combined upper and lower extremity training.

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). The secondary aims are to evaluate whether the combined training modality, compared to a gold standard protocol involving only the lower limbs, is more effective in a) increasing the effort tolerance of the lower limbs; b) increasing the effort tolerance of the upper limbs and c) reducing the energy cost of walking.

Methods:

This is a multicenter RCT study with a low-risk intervention.

Patients with a diagnosis of COPD, according to the Global Initiative for Lung Disease (GOLD) criteria, will be recruited for this purpose and randomly assigned to two groups: Lower limbs (LL) group and lower plus upper limbs (L+UL) group. The single list of randomization was created by a person external to the healthcare staff.

The treatment in the two groups is reported in the intervention section. All training sessions will be supervised by a physiotherapist. The initial training intensity both for lower and upper limbs will be determined on the basis of the load value performed in the last step of the maximal incremental effort test; the load value will be equal to 60% of the maximal wattage observed. Subsequently, the training intensity will be gradually increased during the sessions with a progression based on the symptoms, according to the protocol of Maltais et al. with steps of 10 watts for the lower limbs and 5 watts for the upper limbs.

During the rehabilitation period, formal education (alone or in groups) concerning the knowledge and management of the disease, healthy lifestyle, airway clearance, and inhaled drugs, will also be offered to all patients. Where indicated, airway clearance techniques and/or adaptation to non-invasive home ventilation will be administered.

At baseline, the investigators will collect clinical evaluations as follows:

  • Demographic and anthropometric data
  • Post-bronchodilator spirometry and plethysmography (Forced Expiratory Volume at 1 second, Forced Vital Capacity, Residual Volume, Inspiratory Capacity)
  • Blood gas analysis in ambient air (PaO2, PaCO2, pH)
  • Cumulative Illness Rating Score (CIRS)

Pre and post evaluations will be:

  • Barthel Index
  • EuroQoL

The Outcome measures are reported in the dedicated section.

The sample size has been calculated considering an improvement of the LL group of 23±20 seconds on the GLITTRE test corresponding to the MCID (Minimal Clinical Important Difference) for a standard GOLD rehabilitation treatment using a T-test for unpaired data with a= 0.05, b= 0.80. Estimating that patients in the L+UL group improve 22±20 seconds more than the LL group, the estimated sample is 30 patients (15 per group). Furthermore, considering a drop-out rate of 20%, it is estimated that 36 patients will be enrolled (12 patients per center).

The statistical evaluation will be conducted with the STATA 11 program (StataCorp LLC). Continuous variables will be expressed as mean and standard deviation (or median and quartiles) while categorical or binary variables as a percentage.

Statistical evaluation will be conducted with the use of appropriate parametric and non-parametric tests to verify differences between groups in treatment response (T-test or Wilcoxon to evaluate the difference between means or medians and chi-square test to evaluate the difference between frequencies). A secondary evaluation by logistic regression will also be performed to verify the baseline characteristics predictive of improvement in responders. A p value <.05 will be considered significant.

Study Type

Interventional

Enrollment (Estimated)

36

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 Contact

Study Contact Backup

Study Locations

  • Italy
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • Recruiting
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
        • Contact:
        • Contact:
    • Pavia
      • Montescano, Pavia, Italy, 27040
        • Not yet recruiting
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
        • Contact:
        • Contact:
    • Varese
      • Tradate, Varese, Italy, 21049
        • Completed
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lower limbs (LL) group
These patients will participate in a pulmonary rehabilitation program (usual training) on lower limbs
Other: LL group

The program will include daily sessions of 90 minutes, for a total of 14 sessions, consisting of:

  1. 60 minutes on a stationary bike for the lower limbs (2 sessions per day of 30 minutes) at moderate-high intensity;
  2. 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights.

All sessions will be supervised by a physiotherapist.

Other Names:
  • Active Comparator
Experimental: lower plus upper limbs (L+UL) group
These patients will attend a rehabilitation program combining upper and lower extremity training
Other: L+UL group

These patients will attend a rehabilitation program with daily sessions of 90 minutes, for a total of 14 sessions, consisting of:

  1. 30 minutes on a stationary bike for the lower limbs (1 session of 30 minutes per day) at moderate-high intensity;
  2. 30 minutes with arm-ergometer (1 daily session of 30 minutes) at moderate-high intensity;
  3. 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights.

All sessions will be supervised by a physiotherapist.

Other Names:
  • Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ADLs (GLITTRE test)
Time Frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
To evaluate the improvement in terms of change of exercise time for a specific test (GLITTRE test)
Time Frame. From the date of randomization to the End of the program (up to 16 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in effort tolerance of the lower limbs
Time Frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
To evaluate the improvement in terms of change in the walked distance at 6 minutes walking test (6MWT)
Time Frame. From the date of randomization to the End of the program (up to 16 days)
Change in effort tolerance of the upper limbs
Time Frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
To evaluate the improvement in terms of change in Tlim (time to exhaustion) in the Unsupported Upper Limb Exercise Test (UULEX)
Time Frame. From the date of randomization to the End of the program (up to 16 days)
Change in the energy cost of walking (EC)
Time Frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
To evaluate the improvement in terms of change of the energy cost of walking with the EC test performed on a treadmill at a speed of 3.0 km/h for 6 minutes
Time Frame. From the date of randomization to the End of the program (up to 16 days)

Collaborators and Investigators

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

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Study Director: Michele Vitacca, MD, ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

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)

January 10, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICS Maugeri CE2711

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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