Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance in Patients With Primary Ciliary Dyskinesia

NCT04895150 | Completed

• 1 other identifier: Gazi University 408
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The main aim of the study is to evaluate upper extremity exercise capacity and muscle oxygenation in patients with primary ciliary dyskinesia. The secondary aim of the study is to evaluate respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, balance, physical activity level and quality of life in patients with primary ciliary dyskinesia and compare all parameters with healthy controls.

Conditions

Primary Ciliary Dyskinesia

Keywords

Primary Ciliary Dyskinesia; Upper Extremity Exercise Capacity; Muscle Oxygenation; Balance; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Upper extremity exercise capacity

  Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). A pegboard with two upper and lower bars set at participants shoulder level and above the shoulder level will used. Ten rings will placed on both the lower bars. Patients will be asked to move a single ring at a time with both hands from the lower bars to the upper. The score is the total number of rings moved the six-minute period.

  First Day

• Muscle Oxygenation

  Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). The device will be placed on the 1/3 lower motor point of the quadriceps muscle group of the dominant leg and on the dominant arm deltoid muscle. A minimum of 3 minutes will be waited until the resting measurements and skeletal muscle oxygenation (StO2) signal stabilize. The measurements will be repeated during six minute walking test and six minute pegboard and ring test.

  First Day

Secondary Outcomes (17)

• Functional exercise capacity

  First Day

• Balance

  Second day

• Physical activity (Total energy expenditure)

  Second day

• Physical activity (Active energy expenditure (joule / day)

  Second day

• Physical activity (Physical activity time (min / day)

  Second Day

Study Arms (2)

Patients

Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)) will be evaluated.

Healthy controls;

Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)) will be evaluated.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

At least 18 patients with primary ciliary dyskinesia will be included in patients group and 18 healthy individuals will be included in control group.

You may qualify if:

• Patients;
• years old
• Diagnosed with primary ciliary dyskinesia
• Stability of clinical condition
• Healthy controls;
• years old

You may not qualify if:

• Patients;
• Diagnosed neurological, cognitive problem that can affect evaluations,
• Acute pneumonia or any infection
• History of exacerbation in the last 1 month
• More than 10% change in FEV1 in the last 6 months
• History of coronavirus disease (COVID-19)
• History of smoking
• Diagnosed vision, hearing, vestibular, or neurological problems that can affect balance
• Diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery
• Healthy controls;
• Diagnosed neurological, cognitive problem that can affect evaluations
• Diagnosed vision, hearing, vestibular, or neurological problems that can affect balance
• History of coronavirus disease (COVID-19)
• History of smoking
• Trouble understanding and following the exercise test instruction

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University, Faculty of Health Science

Ankara, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• Valerio G, Giallauria F, Montella S, Vaino N, Vigorito C, Mirra V, Santamaria F. Cardiopulmonary assessment in primary ciliary dyskinesia. Eur J Clin Invest. 2012 Jun;42(6):617-22. doi: 10.1111/j.1365-2362.2011.02626.x. Epub 2011 Nov 29.

  PMID: 22121832 BACKGROUND

• Ring AM, Buchvald FF, Holgersen MG, Green K, Nielsen KG. Fitness and lung function in children with primary ciliary dyskinesia and cystic fibrosis. Respir Med. 2018 Jun;139:79-85. doi: 10.1016/j.rmed.2018.05.001. Epub 2018 May 3.

  PMID: 29858006 BACKGROUND

• Madsen A, Green K, Buchvald F, Hanel B, Nielsen KG. Aerobic fitness in children and young adults with primary ciliary dyskinesia. PLoS One. 2013 Aug 19;8(8):e71409. doi: 10.1371/journal.pone.0071409. eCollection 2013.

  PMID: 23977038 BACKGROUND

• Behan L, Rubbo B, Lucas JS, Dunn Galvin A. The patient's experience of primary ciliary dyskinesia: a systematic review. Qual Life Res. 2017 Sep;26(9):2265-2285. doi: 10.1007/s11136-017-1564-y. Epub 2017 Mar 30.

  PMID: 28361274 BACKGROUND

• Denizoglu Kulli H, Gurses HN, Zeren M, Ucgun H, Cakir E. Do pulmonary and extrapulmonary features differ among cystic fibrosis, primary ciliary dyskinesia, and healthy children? Pediatr Pulmonol. 2020 Nov;55(11):3067-3073. doi: 10.1002/ppul.25052. Epub 2020 Sep 11.

  PMID: 32877003 BACKGROUND

MeSH Terms

Conditions

Ciliary Motility Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Behavior

Study Officials

• Meral Boşnak Güçlü, Prof.Dr.

  Gazi University

  STUDY DIRECTOR

• Şeyma Mutlu, Pt.

  Gazi University

  STUDY CHAIR

• Tuğba ŞİŞMANLAR EYÜBOĞLU, Asc.Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ayşe Tana ARSLAN, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: June 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 15, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)