Evidence map›Paper›PMID 39148115›Full record

ArticleTrials2024

Move-PCD-a multi-center longitudinal randomized controlled superiority trial on the effect of a 6-month individualized supported physical activity (PA) program on quality of life (QoL) in children, adolescents, and adults with primary ciliary dyskinesia.

Anna Teresa Hoffmann, Anna Mai, Klaus Baum, Anne Schlegtendal, Christoph Maier, Julien Stein, Marianne Tokic, Stefanie Dillenhöfer, Thomas Lücke, Nina Timmesfeld and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Anna Teresa HoffmannUniversity Clinic for Pediatrics and Adolescent Medicine, Ruhr University Bochum, Alexandrinenstr. 5, 44791, Bochum, Germany. anna.hoffmann-n28@ruhr-uni-bochum.de.ORCID http://orcid.org/0000-0002-8119-6070
Anna MaiMedical Informatics, Biometry and Epidemiology (AMIB), Ruhr University Bochum, 44780, Bochum, Germany.
Klaus BaumTrainingsinstitut Prof. Dr. Baum, Wilhelm-Schlombs-Allee 1, 50858, Cologne, Germany.
Anne SchlegtendalUniversity Clinic for Pediatrics and Adolescent Medicine, Ruhr University Bochum, Alexandrinenstr. 5, 44791, Bochum, Germany.
Christoph MaierUniversity Clinic for Pediatrics and Adolescent Medicine, Ruhr University Bochum, Alexandrinenstr. 5, 44791, Bochum, Germany.
Julien SteinMedical Informatics, Biometry and Epidemiology (AMIB), Ruhr University Bochum, 44780, Bochum, Germany.
Marianne TokicMedical Informatics, Biometry and Epidemiology (AMIB), Ruhr University Bochum, 44780, Bochum, Germany.
Stefanie DillenhöferUniversity Clinic for Pediatrics and Adolescent Medicine, Ruhr University Bochum, Alexandrinenstr. 5, 44791, Bochum, Germany.
Thomas LückeUniversity Clinic for Pediatrics and Adolescent Medicine, Ruhr University Bochum, Alexandrinenstr. 5, 44791, Bochum, Germany.
Nina TimmesfeldMedical Informatics, Biometry and Epidemiology (AMIB), Ruhr University Bochum, 44780, Bochum, Germany.
Folke BrinkmannUniversity Clinic for Pediatrics and Adolescent Medicine, Ruhr University Bochum, Alexandrinenstr. 5, 44791, Bochum, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrimary ciliary dyskinesia (PCD) is a rare genetical disease with malfunction of the motile cilia leading to impaired muco-ciliary clearance in the respiratory tract. There is no cure for PCD, only supportive therapy aimed at minimizing the progression of the disease and improving the patient's quality of life (QoL). Physical activity (PA) is one of these recommended supportive therapies for people with PCD (pwPCD). However, there is no scientific evidence to support this recommendation. In addition, regular medical advice to increase PA remains largely ineffective in pwPCD.

methodsTo test the main hypothesis, that an individualized and supported PA program leads to a better QoL 6 months after randomization (QoL-PCD questionnaire) compared to usual recommendation in pwPCD, 158 pwPCD aged 7 to 55 years are to be included in this multi-center randomized controlled trial (RCT). After the screening visit, a 1:1 randomization stratified by age group and FEV1 will be performed. A QoL-PCD questionnaire, motor test, and lung function will be carried out at regular intervals in both groups. PA is recorded in both groups using activity trackers during the study period. The main aim of the trial is to estimate the difference in the change of QoL between the groups after 6 months. Therefore, our full analysis set consists of all randomized patients and analysis is performed using the intention-to-treat principle. Statistical software R ( http://www.r-project.org ) is used. Ethical approvement without any reservations: RUB Bochum Ethics Committee (No. 23-7938; December 4, 2023). Recruitment start: March 2024. DISCUSSION: Limitations result from the rarity of PCD with its broad disease spectrum and the large age range. These are reduced by stratified randomization and the measurement of the individual change in QoL as primary endpoint. In our view, only a PA program tailored to individual needs with close contact to trainers offers the chance to meet personal needs of pwPCD and to establish PA as a pillar of therapy in the long term. The study protocol explains all procedures and methods of recruitment, implementation of the study visits and intervention, measures for patient and data safety, and for minimizing risks and bias.

trial registrationGerman Clinical Trials Register (DRKS) 00033030. Registered on December 7, 2023. Update 10 July 2024. STUDY PROTOCOL VERSION 10: Version 1.2; 12 June 2024.

Indexed as

Multicenter Studies as TopicQuality of LifeAdolescentAdultChildCiliary Motility DisordersEquivalence Trials as TopicExerciseExercise TherapyFemaleHumansKartagener SyndromeLongitudinal StudiesMaleMiddle AgedRandomized Controlled Trials as TopicMotor skillsPCDPhysical activity programPhysical fitnessStandard therapy

Identifiers

PMID39148115
PMCPMC11328395

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.