Peripheral Muscle Function in Patients With COPD

Copd Clinical Trial

Official title:

Impact of Pulmonary Rehabilitation on Peripheral Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767126
• Other study ID #: MAC_COPD_FDG
• Status: Completed
• Start date: January 13, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airway obstruction and progressive deterioration of respiratory function. Patients with COPD show a limited exercise tolerance, early fatigability and progressive dyspnea, with important consequences on the ability to sustain even mild efforts and a drastic restriction in the activities of daily living. Muscle dysfunction is a systemic manifestation of COPD that contributes to exertion intolerance in individuals with COPD to the point of compromising fundamental functional activities, such as walking. Previous studies have shown, in fact, that quadriceps strength can be reduced by 20% to 30% in patients with COPD and this value is associated with an increased risk of mortality in patients with lower strength levels. In addition, loss of muscle mass or sarcopenia also occurs with a prevalence of between 8% and 67% in patients with COPD, exacerbating the picture of muscle dysfunction.

One of the goals of respiratory rehabilitation is precisely the prevention of muscle dysfunction in patients with COPD. However, rehabilitation programs aimed at maintaining and recovering muscle strength are often lacking in guidance regarding target muscles, duration of sessions, and training intensity, while strength assessment is often limited by the timing and resources associated with the clinical setting in which it takes place. This makes it difficult to determine its short- and long-term effectiveness.

Therefore, assessment of muscle function in patients with COPD requires tests that are simple and quick to perform, but equally capable of providing quantitative data referable to a specific characteristic of muscle strength as well as indicative of the patient's overall function. In addition, complementary measurements such as body composition and muscle mass, as well as the development of predictive models and normative values of muscle function could provide additional information on the progression of muscle dysfunction in patients with COPD, allowing rehabilitation intervention to be directed toward recovery of the most compromised functions.

Therefore, the aims of this study are: 1) To evaluate the effectiveness of a standard pulmonary rehabilitation program in recovering peripheral muscle dysfunction in patients with COPD. 2) To evaluate the clinical reliability of tests commonly used to measure peripheral muscle function in the rehabilitation setting of patients with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• COPD diagnosis (GOLD stage: II-III-IV), defined as post-bronchodilator forced expiratory volume in 1s (FEV1)/forced vital capacity < 0.7 and FEV1 < 80% predicted.

Exclusion Criteria:

• Restrictive lung disease, unstable conditions, recent exacerbation, infection, embolism, pneumothorax, thoracic or abdominal surgery (less than 3 months before recruitment).

• Cardiologic conditions like myocardial infarction (less than 6 months before recruitment), heart failure, or severe angina.

• Inability of perform the exercise training (e.g. orthopaedic conditions).

• Incapability to understand the instructions required to carry out the tests and assessments planned.

Related Conditions & MeSH terms

• Copd

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Agustí AG. Systemic effects of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2005;2(4):367-70; discussion 371-2. Review. — View Citation

Jones SE, Maddocks M, Kon SS, Canavan JL, Nolan CM, Clark AL, Polkey MI, Man WD. Sarcopenia in COPD: prevalence, clinical correlates and response to pulmonary rehabilitation. Thorax. 2015 Mar;70(3):213-8. doi: 10.1136/thoraxjnl-2014-206440. Epub 2015 Jan 5. — View Citation

Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigaré R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST. Review. — View Citation

Marklund S, Bui KL, Nyberg A. Measuring and monitoring skeletal muscle function in COPD: current perspectives. Int J Chron Obstruct Pulmon Dis. 2019 Aug 19;14:1825-1838. doi: 10.2147/COPD.S178948. eCollection 2019. Review. — View Citation

Nyberg A, Saey D, Maltais F. Why and How Limb Muscle Mass and Function Should Be Measured in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2015 Sep;12(9):1269-77. doi: 10.1513/AnnalsATS.201505-278PS. Review. — View Citation

Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. Epub 2006 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limbs muscle power	Muscle power of the lower limbs measured during the sit-to-stand test	Change from baseline through study completion, an average of 6 weeks
Primary	Lower limbs muscle power	Muscle power of the lower limbs measured during the sit-to-stand test	Change after 3 months from study completion