NCT07655011

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a chronic multisystem disease frequently associated with peripheral muscle dysfunction, which is strongly linked to prognosis and survival. Pulmonary rehabilitation is a cornerstone of COPD management and includes both cardiorespiratory endurance training and muscle strengthening exercises. Although these components are routinely combined within rehabilitation programs, the optimal order in which they should be performed during the same training session remains unclear. In healthy individuals, performing endurance and strength exercises in different sequences within a single session may influence muscular adaptations, a phenomenon referred to as the intra session interference effect. This effect has never been studied in patients with COPD undergoing pulmonary rehabilitation. Given the high prevalence and clinical importance of muscle weakness in COPD, optimizing exercise prescription may improve functional outcomes and long term benefits. This multicenter randomized controlled trial aims to compare two pulmonary rehabilitation strategies that differ only in the order of exercise administration. Participants with moderate to severe COPD will be randomly assigned to perform either muscle strengthening before endurance training or endurance training before muscle strengthening during each rehabilitation session. The primary objective is to evaluate the impact of exercise order on lower limb muscle strength, assessed by the Five Times Sit to Stand test at the end of the rehabilitation program. Secondary objectives include assessment of exercise capacity, dyspnea, muscle and inflammatory biomarkers, tolerance, and adherence to the rehabilitation program, as well as follow up evaluations up to 12 months after completion. The results of this study are expected to provide evidence to optimize pulmonary rehabilitation programs for patients with COPD and to inform clinical practice regarding exercise sequencing.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
42mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

May 20, 2026

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Five Times Sit to Stand Test (5STS)

    Assessment of lower limb muscle strength using a standardized functional test There is no minimum and maximum values in this measure. The higher the score, the worse the result.

    End of pulmonary rehabilitation program (8 weeks)

Secondary Outcomes (13)

  • Five Times Sit to Stand Test (5STS)

    3 months after program completion

  • Five Times Sit to Stand Test (5STS)

    6 months after program completion

  • Five Times Sit to Stand Test (5STS)

    12 months after program completion

  • 6 Minute Walk Test (6MWT)

    End 3 months after program completion

  • 6 Minute Walk Test (6MWT)

    End 6 months after program completion

  • +8 more secondary outcomes

Study Arms (2)

Muscle Strengthening Before Endurance Training (MS-ET)

EXPERIMENTAL

Participants assigned to this arm will follow a standardized pulmonary rehabilitation program in which muscle strengthening exercises are systematically performed before cardiorespiratory endurance training within each rehabilitation session. The overall content, frequency, duration, and intensity of the rehabilitation program are identical to those of the comparison arm; only the intra session order of the exercise components differs. Sessions are conducted three times per week over an eight week period under professional supervision.

Other: Pulmonary Rehabilitation - Strength First

Endurance Training Before Muscle Strengthening (ET-MS)

ACTIVE COMPARATOR

Participants assigned to this arm will follow a pulmonary rehabilitation program in which muscle strengthening exercises within each rehabilitation session is systematically performed before cardiorespiratory endurance training . The rehabilitation program is identical to that of the standardized arm in terms of content, frequency, duration, and intensity. The only difference between the two arms is the intra session order of endurance and strength exercises. Sessions are conducted three times per week over an eight week period under professional supervision.

Other: Pulmonary Rehabilitation - Endurance First

Interventions

All participants receive the same standardized pulmonary rehabilitation program, differing only in the intra-session exercise order. Sessions are supervised, performed 3 times/week for 8 weeks and combine cardiorespiratory endurance and peripheral muscle strengthening. Endurance training consists of 30-45min continuous exercise on a cycle ergometer, treadmill or rowing ergometer, with intensity individually prescribed from baseline exercise testing and adjusted according to tolerance and dyspnea. Strength training lasts 45-60min and targets upper- and lower-limb muscles using dumbbells, elastic bands, body-weight exercises and leg press. Initial training loads are determined from indirect 1-RM estimation. After a familiarization phase, patients perform 6 alternating upper/lower-limb exercises in 3 sets of 8-12 repetitions near maximal effort, with standardized rest periods and movement tempo. Loads are progressively increased according to repetition performance and patient tolerance.

Muscle Strengthening Before Endurance Training (MS-ET)

All participants receive the same standardized pulmonary rehabilitation program, differing only in the intra-session exercise order. Sessions are supervised, performed 3 times/week for 8 weeks and combine cardiorespiratory endurance and peripheral muscle strengthening. Endurance training consists of 30-45min continuous exercise on a cycle ergometer, treadmill or rowing ergometer, with intensity individually prescribed from baseline exercise testing and adjusted according to tolerance and dyspnea. Strength training lasts 45-60min and targets upper- and lower-limb muscles using dumbbells, elastic bands, body-weight exercises and leg press. Initial training loads are determined from indirect 1-RM estimation. After a familiarization phase, patients perform 6 alternating upper/lower-limb exercises in 3 sets of 8-12 repetitions near maximal effort, with standardized rest periods and movement tempo. Loads are progressively increased according to repetition performance and patient tolerance

Endurance Training Before Muscle Strengthening (ET-MS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • COPD GOLD stages 2 to 4
  • Admitted for pulmonary rehabilitation in a participating center
  • Ability to read and speak French
  • Written informed consent
  • Affiliation with a social security system

You may not qualify if:

  • Legal protection (guardianship or trusteeship)
  • Pregnancy beyond the second trimester
  • Musculoskeletal disorders affecting lower limb strength or walking performance
  • Vascular disease limiting walking distance
  • Cardiac contraindication to pulmonary rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations