Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

A Comparison of Exercise Capacity, Arterial Stiffness, and Cognitive Function Between Adults With Cystic Fibrosis and Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175182
• Other study ID #: GO 22/917
• Status: Recruiting
• Start date: December 14, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: Hacettepe University
• Contact: Zeynep Soyoglu, M.Sc
• Phone: +90-312-305 2525
• Email: zzeynep.soyoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

No studies in the literature have investigated the simultaneous effects of cognitive function, exercise capacity and arterial stiffness in adult patients with CF. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation, and arterial stiffness of adult patients with CF and healthy subjects.

Description:

Cystic fibrosis (CF) affects other body systems as well as the respiratory system. Patients with CF seem to have reduced exercise capacity, which is a major contributor to mortality rates. Changes in lung function, ventilatory dysfunction, and respiratory muscle function potentially contribute to exercise intolerance in CF. Both children and adults with CF exhibit neurocognitive dysfunction. Arterial stiffness is a predictor of cardiovascular events, including myocardial infarction, heart failure, and mortality. Individuals with CF exhibit an increase in arterial stiffness. However, no studies in the literature have investigated cognitive function, exercise capacity, and arterial stiffness coexistence in adult CF patients. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation and arterial stiffness in adult patients with CF and healthy subjects. Additionally, it will determine the relationship between cognitive function and arterial stiffness with exercise capacity and muscle oxygenation during exercise in adult patients with CF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having been diagnosed with cystic fibrosis

• Being 18 years old and older

• Clinically stable condition

• Able to cooperate with the tests performed

• Volunteered to participate in the study

For the control group:

• Being 18 years old and older

• Volunteered to participate in the study

Exclusion Criteria:

• History of hospitalization or exacerbation in the last month.

• Chronic respiratory failure and long-term use of oxygen therapy

• Using noninvasive mechanical ventilator therapy

• Indication for lung transplantation

• Who had a lung transplant

• Forced expiratory volume in the first second (FEV1) value 30% and below

• CF-related diabetes

• Chronic liver disease

• Allergic bronchopulmonary aspergillosis

• Systemic steroid use

• History of diagnosed orthopedic or musculoskeletal problems affecting mobility

• Cardiovascular instability

• Serious psychiatric illness

For the control group:

• Known chronic or systemic disease

• Who did not volunteer to participate in the study

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.	6 minutes
Primary	Arterial Stiffness Assessment	Arterial stiffness is determined using a oscillometric cuff device (Tel-O-Graph BT, I.E.M., Stolberg, Germany). Pulse wave velocity (PWV) and augmentation index (AIx) are measured by brachial pulse waves.	20 minutes
Primary	Cognitive Assessment- MoCA	Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) test. The MoCA test is a questionnaire developed to evaluate different cognitive functions and mild cognitive impairment. The maximum score that an individual can obtain from the test is 30, and a score of 26 above is considered as mild cognitive impairment.	10 minutes
Primary	Cognitive Assessment-Mini Mental Test	Cognitive function is measured using the Mini Mental Test. A higher score indicates better cognitive function. The maximum score that an individual can obtain from the test is 30, and a score of 23 and above is considered as cognitive impairment.	10 minutes
Primary	Muscle Oxygenation Assessment	Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).	10 minutes
Secondary	Body Composition	Body fat is measured using skinfold thickness assessment.	5 minutes
Secondary	Pulmonary Function Test (forced vital capacity (FVC))	Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced vital capacity (FVC).	10 minutes
Secondary	Pulmonary Function Test (forced expiratory volume in the first second (FEV1))	Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory volume in the first second (FEV1).	10 minutes
Secondary	Pulmonary Function Test (FEV1/FVC)	Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses FEV1/FVC.	10 minutes
Secondary	Pulmonary Function Test (peak flow rate (PEF))	Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses peak flow rate (PEF).	10 minutes
Secondary	Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))	Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory flow from 25-75% (FEF25-75%).	10 minutes
Secondary	Respiratory Muscle Strength	Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measured using a mouth pressure measuring device with personal antibacterial and antiviral disposable filters.	10 minutes
Secondary	Peripheral Muscle Strength	Knee extensor muscle strength is measured utilizing a portable device.	5 minutes
Secondary	Anxiety and Depression	The Hospital Anxiety and Depression scale (HADS) is used to evaluate anxiety and depression. Higher scores correspond to more anxiety and depression symptoms.	5 minutes
Secondary	Physical Activity Assessment	Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week. Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity. The results for all activity-based items are summed for the total physical activity score. The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.	5 minutes
Secondary	Sleep Quality	Sleep quality is evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale total score is between 0 and 21. A total score of 5 and above indicates poor sleep quality.	5 minutes
Secondary	Disease Specific Quality of Life	Disease-specific quality of life is evaluated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R). The CFQ-R includes 50 items across 12 domains. Each domain is standardized on a 0-100 scale; higher scores indicate better quality of life.	8 minutes
Secondary	General Health-Related Quality of Life	Health-related quality of life is assessed using the Nottingham Health Profile (NHP). It is a general QOL questionnaire designed to measure perceived health problems and the extent to which these problems affect normal daily activities. It consists of 38 items in six dimensions (energy level, pain, physical mobility, emotional reactions, social isolation, and sleep). The total score for each section is 0-100. High scores indicate worse quality of life.	5 minutes