Bewegungstraining und Nierentransplantation (EXTRA)
Physiologische und molekulare Auswirkungen von körperlichem Training bei Empfängern von Nierentransplantationen
The goal of this clinical trial is to investigate the physiological and molecular effects of exercise training in transplant recipients. The main questions it aims to answer are:
- Can exercise training improve physical fitness and muscle strength in transplant recipients?
- Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients?
- Can exercise training improve blood pressure and endothelial health in transplant patients?
Participants will be invited to an exercise training program 6-month after their transplant surgery. Body composition, physical assessment, and blood draw will be assessed at baseline and 24-weeks after exercise or control regimen.
Researchers will compare exercise group vs. routine care group to see if exercise training impact the health-related outcomes of this population.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study will involve inviting participants to join an exercise training program six months after their transplant surgery. The research will include baseline assessments and measurements, such as body composition, physical assessment, and blood draws. These assessments will be conducted both at the beginning of the study and 24 weeks after participants have undergone either the exercise regimen or a control regimen.
The research team will compare two groups: the exercise group and the routine care group. The goal is to examine whether participating in an exercise training program has a significant impact on various health-related outcomes in transplant recipients when compared to individuals receiving standard care.
This clinical trial seeks to understand the potential benefits of exercise training on physical fitness, quality of life, inflammatory and molecular profiles, as well as cardiovascular health in individuals who have undergone organ transplantation. The comparison between the exercise group and the routine care group will provide valuable insights into the effectiveness of exercise interventions for this specific population.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Medical Authorization:
- Stable Health Status
- Medication Consistency
- No History of Severe Cardiovascular Events
- No Major Orthopedic Issues
- Non-Smokers or Consistent Smoking Habits
- Ability to Comply with Study Protocols
Exclusion Criteria:
- Inability to Comply
- Cognitive disorders
- Unwillingness to Continue
- Unstable Health Conditions
- Physical limitations during the protocol
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Exercise training group
The training programs will encompass three phases, with a gradual progression in both intensity and duration. Each phase will span a duration of four weeks, culminating in a comprehensive 24-week training regimen. |
Participants will engage in combined training five times a week, with activities including 2 minutes of stationary marching and a set of 15 repetitions for squats, bilateral hip abduction, plantar flexion, floor abdominal exercises, and arm flexion with the knee close to the ground. Additionally, twice a week on non-consecutive days, volunteers partake in 20 minutes of aerobic walking. The second program starts with a 2-minute stationary march, followed by 2 sets of 12 repetitions for free squats, hip abduction, plantar flexion, stiff-legged deadlifts, arm flexion with knee support, floor abdominal exercises, and concludes with 30 minutes of aerobic exercise. The third program starts with a 2-minute stationary march, followed by 3 sets of 12 repetitions for free squats, hip abduction, plantar flexion, stiff-legged deadlifts, arm flexion, floor abdominal exercises, and includes thrice-weekly aerobic sessions lasting 30 minutes each.
Andere Namen:
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Kein Eingriff: Control group
Control group will continue their usual care without exercise interventions. |
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Aktiver Komparator: Continue exercise
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will include individuals who choose to persist with their exercise routine. |
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will include individuals who choose to persist with their exercise routine. |
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Aktiver Komparator: Discontinue exercise
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will comprise individuals who opted not to continue their exercise routine. |
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will comprise individuals who opted not to continue their exercise routine. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Physical fitness - VO2peak
Zeitfenster: Baseline, after 24-weeks and at the end of the protocol
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Cardiopulmonary test |
Baseline, after 24-weeks and at the end of the protocol
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Isometric muscle strength
Zeitfenster: Baseline, after 24-weeks and at the end of the protocol
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Handgrip strength |
Baseline, after 24-weeks and at the end of the protocol
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Inflammatory profile
Zeitfenster: Baseline, after 24-weeks and at the end of the protocol
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Interleukin 6, interleukin 10, and tumor necrosis factor |
Baseline, after 24-weeks and at the end of the protocol
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Urea-to-creatinine ratio
Zeitfenster: Baseline, after 24-weeks and at the end of the protocol
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Urea and creatinine will be combined to report urea-to-creatinine ratio |
Baseline, after 24-weeks and at the end of the protocol
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Blood glucose
Zeitfenster: Baseline, after 24-weeks and at the end of the protocol
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Fasting blood glucose levels |
Baseline, after 24-weeks and at the end of the protocol
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Graft rejection
Zeitfenster: Through study completion, an average of 2 years
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Number of patients that rejected their graft |
Through study completion, an average of 2 years
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Erkrankungen des Nervensystems
- Muskelerkrankungen
- Neuromuskuläre Manifestationen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Chronische Erkrankung
- Krankheitsattribute
- Niereninsuffizienz
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Entzündung
- Muskelschwäche
- Nierenversagen, chronisch
- Niereninsuffizienz, chronisch
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Therapeutika
- Physiotherapiemodalitäten
- Patientenversorgung
- Rehabilitation
- Nachbehandlung
- Kontinuität der Patientenversorgung
- Übung
- Trainingstherapie
Andere Studien-ID-Nummern
- 79266224.1.0000.0029
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Data obtained through this study may be provided to qualified researchers with academic interest in exercise and transplantation. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
IPD-Sharing-Zeitrahmen
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
IPD-Sharing-Zugriffskriterien
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Art der unterstützenden IPD-Freigabeinformationen
- SAFT
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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