Muscle Fatigue in People With Cystic Fibrosis: Insight From a Mobile App

NCT07135869 | Completed

• 1 other identifier: CE042404
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle fitness is an important component of health. For instance, the ability to resist to muscle fatigue development is important for daily functioning. Previous studies have suggested altered muscle function in people with cystic fibrosis. However, it is unclear whether such findings still apply in the modern era of CF. Several studies suggested that recent improvements in therapeutics, including CFTR modulators, may have positive effects on the skeletal muscles, potentially normalizing the ability to resist to muscle fatigue. However, no studies to date compared muscle fatigue between people with cystic fibrosis and healthy controls in a large sample of patients. One difficulty is that muscle fatigue assessment requires high-cost dynamometric instruments, which also leads to a gap between research and clinical practice. Our research group has created a mobile application based on video analysis of the chair rising test that reports values of time, velocity and power as reliable as devices found in a laboratory environment. The application has been shown to be valid and reproducible for measuring muscle fatigue in healthy people. However, a validation is necessary before recommending its use in people with cystic fibrosis.

Conditions

Cystic Fibrosis (CF)

Keywords

Cystic Fibrosis; Fatigue; Fatigability; Mobile app; Validity; Reliability; Muscle power; Strength; Peripheral muscle function

Outcome Measures

Primary Outcomes (4)

• Rising Time

  Rising time derived from the mobile application (Sit to Stand App) will be carried out before (Pre), immediately after (Post) and one minute after (Post1min) the fatigue protocol. The differences between the Pre and Post measurements will be indicative of fatigability, while the differences between the Post and Post1min measurements will be indicative of recovery. We will follow the protocol published previously (https://doi.org/10.1007/s00421-024-05537-9).

  Twice separated by 30 minutes to assess reliability.

• Sit to Stand Velocity

  Velocity derived from the mobile application (Sit to Stand App) will be carried out before (Pre), immediately after (Post) and one minute after (Post1min) the fatigue protocol. The differences between the Pre and Post measurements will be indicative of fatigability, while the differences between the Post and Post1min measurements will be indicative of recovery. We will follow the protocol published previously (https://doi.org/10.1007/s00421-024-05537-9).

  Twice separated by 30 minutes to assess reliability.

• Sit to Stand Power

  Power derived from the mobile application (Sit to Stand App) will be carried out before (Pre), immediately after (Post) and one minute after (Post1min) the fatigue protocol. The differences between the Pre and Post measurements will be indicative of fatigability, while the differences between the Post and Post1min measurements will be indicative of recovery. We will follow the protocol published previously (https://doi.org/10.1007/s00421-024-05537-9).

  Twice separated by 30 minutes to assess reliability.

• One minute sit-to-stand test

  The one minute sit-to-stand test will be carried out according to the Guidance and standard operating procedures for functional exercise testing in cystic fibrosis (https://doi.org/10.1183/16000617.0029-2023). The number of repetitions performed during the test will be collected.

  Twice separated by 30 minutes to assess reliability.

Secondary Outcomes (4)

• Heart rate

  Twice separated by 30 minutes to assess reliability.

• Muscle effort

  Twice separated by 30 minutes to assess reliability.

• Respiratory effort

  Twice separated by 30 minutes to assess reliability.

• Oxygen saturation

  Twice separated by 30 minutes to assess reliability.

Study Arms (2)

Fatigue protocol for cystic fibrosis

The one minute sit-to-stand test will be used as fatigue protocol.

Diagnostic Test: One minute sit-to-stand test

Fatigue protocol for healthy controls

The one minute sit-to-stand test will be used as fatigue protocol

Diagnostic Test: One minute sit-to-stand test

Interventions

One minute sit-to-stand test DIAGNOSTIC_TEST

The one minute sit-to-stand test will be used as acute fatigue protocol to generate fatigue.

Fatigue protocol for cystic fibrosis; Fatigue protocol for healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with cystic fibrosis, recruited from the registry of the Cystic Fibrosis Association of Murcia, and healthy control participants matched by age and sex.

You may qualify if:

• Clinically stable.
• Not requiring oxygen therapy during the test.
• No history of lung or liver transplants.

You may not qualify if:

• Any musculoskeletal conditions that could limit or influence test performance.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Asociación Murciana de Fibrosis Quistica

Murcia, 30120, Spain

Location

Related Publications (6)

• Saynor ZL, Gruet M, McNarry MA, Button B, Morrison L, Wagner M, Sawyer A, Hebestreit H, Radtke T, Urquhart DS; European Cystic Fibrosis Society Exercise Working Group. Guidance and standard operating procedures for functional exercise testing in cystic fibrosis. Eur Respir Rev. 2023 Aug 9;32(169):230029. doi: 10.1183/16000617.0029-2023. Print 2023 Sep 30.

  PMID: 37558263 BACKGROUND

• Ruiz-Cardenas JD, Rodriguez-Juan JJ, Smart RR, Jakobi JM, Jones GR. Validity and reliability of an iPhone App to assess time, velocity and leg power during a sit-to-stand functional performance test. Gait Posture. 2018 Jan;59:261-266. doi: 10.1016/j.gaitpost.2017.10.029. Epub 2017 Oct 31.

  PMID: 29102856 BACKGROUND

• Martinez-Garcia MDM, Rodriguez-Juan JJ, Ruiz-Cardenas JD. Influence of sex gap on muscle strength and functional mobility in patients with cystic fibrosis. Appl Physiol Nutr Metab. 2020 Apr;45(4):387-392. doi: 10.1139/apnm-2019-0484. Epub 2019 Sep 17.

  PMID: 31526325 BACKGROUND

• Ruiz-Cardenas JD, Montemurro A, Del Mar Martinez-Garcia M, Rodriguez-Juan JJ. Concurrent and discriminant validity and reliability of an Android App to assess time, velocity and power during sit-to-stand test in community-dwelling older adults. Aging Clin Exp Res. 2023 Aug;35(8):1631-1640. doi: 10.1007/s40520-023-02451-6. Epub 2023 Jun 12.

  PMID: 37306926 BACKGROUND

• Souron R, Ruiz-Cardenas JD, Gruet M. The 1-min sit-to-stand test induces a significant and reliable level of neuromuscular fatigability: insights from a mobile app analysis. Eur J Appl Physiol. 2024 Nov;124(11):3291-3301. doi: 10.1007/s00421-024-05537-9. Epub 2024 Jun 20.

  PMID: 38900202 BACKGROUND

• Gruet M, Troosters T, Verges S. Peripheral muscle abnormalities in cystic fibrosis: Etiology, clinical implications and response to therapeutic interventions. J Cyst Fibros. 2017 Sep;16(5):538-552. doi: 10.1016/j.jcf.2017.02.007. Epub 2017 Mar 2.

  PMID: 28262570 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Fatigue

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan D Ruiz-Cárdenas, PhD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion: May 12, 2026
• Study Completion: May 12, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)