Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention.

NCT06335992 | Recruiting DMC

• 1 other identifier: Dnr 2022-00831-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions. Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program. (ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life. (iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine. (iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Exercise; Regeneration

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function

  FEV1 (Forced Expiratory volume in one second)

  Baseline, post intervention at 12 wks

Secondary Outcomes (5)

• Physical capacity

  Baseline, post intervention at 12 wks

• Inflammation markers

  Baseline, post intervention at 12 wks

• Level of emphysema

  Baseline, post intervention at 12 wks

• Maximal physical capacity ( Wmax)

  Baseline, post intervention at 12 wks

• COPD Assessment Test (CAT)

  Baseline, post intervention at 12 wks

Study Arms (1)

Exercise

EXPERIMENTAL

The exercise training protocol to be used in this study: Supervised exercise training (aerobic- and muscle strengthening exercise): 2 times a week for 12 weeks. * Aerobic exercise with ergometer cycling for 30 min, at moderate intensity (60% Wpeak) individually adjusted to level 4-6 on the Borg category ratio-10 scale. * Muscle strengthening exercise will consist of 8-12 strength exercises of the major upper and lower body muscle groups. Each exercise includes three sets with 8-12 repetitions. Exercise training at home: once a week for 12 weeks.

Other: Exercise regime

Interventions

Exercise regime OTHER

Exercise

Exercise

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Forced expiratory volume in one second (FEV1) 85-30 % of predicted post bronchodilator
• Optimal medical treatment according to GOLD and the Swedish National Guidelines
• Absence of other significant diseases that could contribute to physical exercise limitation
• Non-smoking since at least one year
• Free from exacerbations (last 4 weeks)
• BMI = 18- 35

You may not qualify if:

• Regular participation in adjusted/specially designed exercise sessions
• Unstable cardiovascular or pulmonary disease
• Smoking
• Any other criteria that at the discretion of the investigator prevent the study subject from participating in an exercise-training program

Sponsors & Collaborators

• Uppsala University: lead
• Lund University: collaborator

Study Sites (2)

Lund University

Lund, Sweden

RECRUITING

Uppsala University

Uppsala, Sweden

RECRUITING

Related Publications (1)

• Larsson C, Elowsson L, Tufvesson E, Cederberg A, Ohrneman H, Falcones B, Karlsson L, Akbarshahi H, Ankerst J, Bjermer L, Palm A, Londahl J, Malinovschi A, Janson C, Emtner M, Westergen-Thorsson G. Activation of regenerative pathways by exercise intervention in subjects with chronic obstructive pulmonary disease - a study protocol. Respir Res. 2025 Dec 12. doi: 10.1186/s12931-025-03443-y. Online ahead of print.

  PMID: 41388411 DERIVED

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 28, 2024
• Study Start: September 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)