Træning og nyretransplantation (EXTRA)
Fysiologiske og molekylære effekter af træning hos nyretransplantationsmodtagere
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
|
Ingen indgriben: Control group
Control group will continue their usual care without exercise interventions. |
|
|
Aktiv 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. |
|
Aktiv 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical fitness - VO2peak
Tidsramme: Baseline, after 24-weeks and at the end of the protocol
|
Cardiopulmonary test |
Baseline, after 24-weeks and at the end of the protocol
|
|
Isometric muscle strength
Tidsramme: Baseline, after 24-weeks and at the end of the protocol
|
Handgrip strength |
Baseline, after 24-weeks and at the end of the protocol
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Inflammatory profile
Tidsramme: Baseline, after 24-weeks and at the end of the protocol
|
Interleukin 6, interleukin 10, and tumor necrosis factor |
Baseline, after 24-weeks and at the end of the protocol
|
|
Urea-to-creatinine ratio
Tidsramme: Baseline, after 24-weeks and at the end of the protocol
|
Urea and creatinine will be combined to report urea-to-creatinine ratio |
Baseline, after 24-weeks and at the end of the protocol
|
|
Blood glucose
Tidsramme: Baseline, after 24-weeks and at the end of the protocol
|
Fasting blood glucose levels |
Baseline, after 24-weeks and at the end of the protocol
|
|
Graft rejection
Tidsramme: Through study completion, an average of 2 years
|
Number of patients that rejected their graft |
Through study completion, an average of 2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Sygdomme i nervesystemet
- Muskelsygdomme
- Neuromuskulære manifestationer
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Betændelse
- Muskelsvaghed
- Nyresvigt, kronisk
- Nyreinsufficiens, kronisk
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Patientpleje
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Øvelse
- Træningsterapi
Andre undersøgelses-id-numre
- 79266224.1.0000.0029
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
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).
IPD-deling Understøttende informationstype
- SAP
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .