Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.

NCT04757714 | Withdrawn

• 1 other identifier: CHRO-2020-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a condition characterized by a progressive and incompletely reversible limitation of airborne gas flow . The association of co-morbidities with COPD and acute flare-ups of respiratory failure contribute to the overall severity of this disease. The prevalence of COPD is high, affecting up to 10% of people over the age of 40 years and causing high morbidity and mortality rates. While COPD is a disease primarily affecting the lungs, it is associated with many extra-pulmonary conditions including sleep apnea, depression, anemia, chronic kidney failure, wasting, cardiovascular disease, skeletal muscle weakness and osteoporosis (OP).

Conditions

COPD; Osteoporosis; Kyphosis

Keywords

osteoporosis

Outcome Measures

Primary Outcomes (2)

• The thoracic kyphosis index

  The kyphosis index will be used to assess thoracic kyphosis at the beginning of the study. This index is a percentage.

  Day 0

• Forced vital capacity

  Day 0

Secondary Outcomes (13)

• Presence of densitometric osteoporosis

  Day 0

• Presence of intermediate bone density

  Day 0

• Percentage of maximum expiratory volume per second (FEV1), percentage predicted value

  Day 0

• predicted value FEV1/Forced Vital Capacity

  Day 0

• Quality of life score (St George Hospital questionnaire)

  Day 0

Study Arms (1)

COPD Patients

OTHER

Patients agreeing to participate in the study and meeting the inclusion and non-inclusion criteria will have: * The high-resolution peripheral scanner (HRpQCT) of the tibia and radius * a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) * to complete: * a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital) * A search for sarcopenia by studying the strength of the grip (dynamometer)

Procedure: The high-resolution peripheral scanner (HRpQCT) of the tibia and radius; Procedure: a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system); Other: Questionnaires; Other: A search for sarcopenia by studying the strength of the grip (dynamometer)

Interventions

The high-resolution peripheral scanner (HRpQCT) of the tibia and radius PROCEDURE

The high-resolution peripheral scanner (HRpQCT) of the tibia and radius

COPD Patients

a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) PROCEDURE

a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)

COPD Patients

Questionnaires OTHER

* a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital)

COPD Patients

A search for sarcopenia by studying the strength of the grip (dynamometer) OTHER

A search for sarcopenia by studying the strength of the grip (dynamometer)

COPD Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman age \> 40
• FEV1/CVF ratio \< 0.7 as defined by the Global Initiative for Chronic Obstruction Lung Disease (GOLD).
• Moderate to severe COPD as defined by GOLD (grade C and D)

You may not qualify if:

• Presence of metal or plastic parts in the field of examination
• Pregnancy
• Patients who are not affiliated with or do not benefit from a social security system
• Person under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'ORLEANS

Orléans, 45067, France

Location

Related Publications (5)

• Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.

  PMID: 14999112 BACKGROUND

• Cielen N, Maes K, Gayan-Ramirez G. Musculoskeletal disorders in chronic obstructive pulmonary disease. Biomed Res Int. 2014;2014:965764. doi: 10.1155/2014/965764. Epub 2014 Mar 25.

  PMID: 24783225 BACKGROUND

• Decramer M, Janssens W, Miravitlles M. Chronic obstructive pulmonary disease. Lancet. 2012 Apr 7;379(9823):1341-51. doi: 10.1016/S0140-6736(11)60968-9. Epub 2012 Feb 6.

  PMID: 22314182 BACKGROUND

• Eagan TM, Aukrust P, Ueland T, Hardie JA, Johannessen A, Mollnes TE, Damas JK, Bakke PS, Wagner PD. Body composition and plasma levels of inflammatory biomarkers in COPD. Eur Respir J. 2010 Nov;36(5):1027-33. doi: 10.1183/09031936.00194209. Epub 2010 Apr 22.

  PMID: 20413541 BACKGROUND

• Ekblom O, Ekblom-Bak E, Bolam KA, Ekblom B, Schmidt C, Soderberg S, Bergstrom G, Borjesson M. Concurrent and predictive validity of physical activity measurement items commonly used in clinical settings--data from SCAPIS pilot study. BMC Public Health. 2015 Sep 28;15:978. doi: 10.1186/s12889-015-2316-y.

  PMID: 26415512 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Osteoporosis; Kyphosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Curvatures; Spinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric LESPESSSAILLES, Ph.D.

  CHR ORLEANS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

FR (1)