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Remotely Supervised Exercise for Adults With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05173194
Recruitment Status : Recruiting
First Posted : December 29, 2021
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Margarita Perez, Universidad Europea de Madrid

Brief Summary:
Cystic fibrosis (CF) is a genetic disease characterized by abnormal chloride transport in epithelial tissues. Inflammation is a key component contributing to the main alterations induced by the disease. The increase in life expectancy comes with a higher prevalence of CF-related comorbidities, but also with new emerging complications directly related to aging. Physical fitness and exercise practice have been previously associated to survival and better quality of life in patients with cystic fibrosis. Thus, the aim of this study is to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Exercise Not Applicable

Detailed Description:
This study aims to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Evaluators of outcomes will be masked as for the study group of each participant.
Primary Purpose: Treatment
Official Title: Effects of a Remotely Supervised Exercise Program on Inflammatory Markers, Muscle Strength and Lung Function in Adult Patients With Cystic Fibrosis
Actual Study Start Date : October 26, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Telematic Exercise
A remotely supervised resistance exercise program will be carried out for 8 weeks, with three weekly sessions lasting approximately 60 minutes each. Training will be performed in groups of four patients, according to their lung function/physical fitness. The first training session will be on site (University) for familiarization, planning and adjustment of the exercises, and the following sessions will be performed online. Each session is divided into: (i) Warm-up and joint mobility; (ii) main part: strength exercises for different muscle groups; and (iii) cool down: stretching and breathing exercises.
Other: Exercise
Eight-week program of a remotely supervised resistance exercise. Frequency: three times per week. Duration: 60 minutes per session. Training program: warm-up and joint mobility; strength exercises for different muscle groups; and cool down (stretching and breathing exercises).

No Intervention: Control
Control group will follow routine recommendations from the multidisciplinary CF team.



Primary Outcome Measures :
  1. Change in peripheral muscle strength. Upper and lower limb muscle strength will be evaluated using the 5 maximum repetition test in specific strength machines. Handgrip strength will be measured with a dynamometer. [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks

  2. Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA) [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks

  3. Change in plasmatic levels of Klotho [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks

  4. Change in plasmatic levels of interleukins (IL-8 and IL-10) [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks


Secondary Outcome Measures :
  1. Change in Pulmonary Function (Lung Function) [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks

  2. Change in quality of life evaluated using the Cystic Fibrosis Questionnaire (CFQ-R +14). Scores range from 0 to 100 with higher scores corresponding to better quality of life. [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks

  3. Change in inspiratory muscle strength (MIP) [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks

  4. Change in functional capacity (30 seconds sit-to-stand test) [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed clinical and genetic diagnosis for cystic fibrosis;
  • Age from 16 years.

Exclusion Criteria:

  • Musculoskeletal disorders that do not allow the performance of physical exercise;
  • Pregnancy;
  • Absence of registration of clinical required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05173194


Contacts
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Contact: Margarita Perez Ruiz, PhD +34912115200 ext 3010 pruizmarga@gmail.com

Locations
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Spain
Hospital La Princesa Recruiting
Madrid, Spain, 28006
Contact: Rosa María Girón Moreno, PhD    +34915202200    rmgiron@gmail.com   
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Margarita Perez Ruiz, PhD Universidad Europea de Madrid
Publications:

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Responsible Party: Margarita Perez, Professor in Exercise Physiology, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT05173194    
Other Study ID Numbers: FQKloE-II
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita Perez, Universidad Europea de Madrid:
Cystic fibrosis
Exercise program
Lung funcion
Inflammation
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases