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

NCT05708443 | Recruiting

• 1 other identifier: ICS Maugeri CE2711
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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).

Conditions

COPD

Keywords

ADL; COPD; Glittre Test; exercise

Outcome Measures

Primary Outcomes (1)

• Change in ADLs (GLITTRE test)

  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 Outcomes (3)

• Change in effort tolerance of the lower limbs

  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. 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. From the date of randomization to the End of the program (up to 16 days)

Study Arms (2)

lower limbs (LL) group

ACTIVE COMPARATOR

These patients will participate in a pulmonary rehabilitation program (usual training) on lower limbs

Other: LL group

lower plus upper limbs (L+UL) group

EXPERIMENTAL

These patients will attend a rehabilitation program combining upper and lower extremity training

Other: L+UL group

Interventions

LL group OTHER

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.

Also known as: Active Comparator

lower limbs (LL) group

L+UL group OTHER

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.

Also known as: Experimental

lower plus upper limbs (L+UL) group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (3)

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano

Montescano, Pavia, 27040, Italy

NOT YET RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate

Tradate, Varese, 21049, Italy

COMPLETED

Related Publications (29)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Michele Vitacca, MD

  ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane

  STUDY DIRECTOR

Central Study Contacts

Mara Paneroni, MSc, PT

CONTACT

0039+030+8253; mara.paneroni@icsmaugeri.it

Tiziana Bachetti, Pharm

CONTACT

+0039+0382+593; tiziana.bachetti@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 1, 2023
• Study Start: January 10, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

IT (3)