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Eine Studie entspricht den Filterkriterien
Kartenansicht
The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults (BRIO)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06940037 (BRIO) ist eine interventionsstudie zur Untersuchung von Altern, Mobility Disability und hat den Status offene rekrutierung. Die Studie startete am 11. August 2025 und soll 300 Teilnehmer aufnehmen. Durchgeführt von Mayo-Klinik ist der Abschluss für 31. August 2030 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 16. September 2025 aktualisiert.
Kurzbeschreibung
To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults.
Offizieller Titel
The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults (BRIO): A Randomized, Placebo-controlled Trial of Progressive Resistance Training in Older Adults.
Erkrankungen
AlternMobility DisabilityWeitere Studien-IDs
- BRIO
- 24-010008
- R01AG089150 (Zuwendung/Vertrag der US-NIH)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-08-11
Zuletzt aktualisiert
2025-09-16
Studienende (vorauss.)
2030-08-31
Geplante Rekrutierung
300
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
aging
mobility
exercise
senescence
DNA methylation
skeletal muscle
mobility
exercise
senescence
DNA methylation
skeletal muscle
Primäres Ziel
Grundlagenforschung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
AndereProgressive Resistance Training participants will attend exercise session 3 times per week. | Progressives Widerstandstraining 3 times a week |
AndereHealth Education participants will attend health educations classed 1 time per week. | Gesundheitserziehung once a week |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Precisely define the variability in changes in physical function | Measured by the Short Physical Performance Battery (SPPB), a 0-12 categorical scale of walking speed, standing balance, and repeated sit-to-stand time, with higher scores reflecting better physical function. | baseline, 6 months |
Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test | Blood glucose concentrations (millimoles/liter) will be measured in response to a physiologically relevant meal challenge. Lower values are indicative of better metabolic health. | baseline, 6 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Precisely define the variability in changes in skeletal muscle size. | Measured by computed tomography scans of the mid-thigh. Larger muscle cross-sectional area (cm\^2) reflects a greater quantity of skeletal muscle. | baseline, 6 months |
Precisely define the variability in changes in skeletal muscle strength. | Measured by the one-repetition maximum, in newtons, on a leg press device, with higher scores reflecting greater skeletal muscle strength. | baseline, 6 months |
Precisely define the variability in changes in six-minute walk distance. | Measured by the distance (meters) walked in six minutes, with longer distances reflecting better physical function. | baseline, 6 months |
Precisely define the variability in insulin secretion in response to a mixed meal tolerance test. | Blood insulin concentrations (pmol/L) will be measured in response to a physiologically relevant meal challenge. Insulin concentrations in a physiological range reflect better metabolic health, while low insulin concentrations can reflect an impaired insulin response and high insulin concentrations can reflect peripheral insulin resistance. | baseline, 6 months |
Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood. | Measured by the percentage of glycated hemoglobin in the blood (often referred to as HbA1c). A lower percentage of HbAlc reflects lower blood glucose concentrations over the past two to three months. | baseline, 6 months |
Precisely define the variability in changes in blood lipids. | Blood lipids, including total cholesterol, low density lipoproteins (LDLs), high density lipoproteins (HDLs), and triglycerides will be measured. Lower levels of total cholesterol (mg/dL), LDLs (mg/dL), and triglycerides (mg/dL), and higher levels of HDLs (mg/dL), are reflective of better metabolic health. | baseline, 6 months |
Precisely define the variability in changes in waist-to-hip ratio. | The circumference (cm) of the waist and hips will be measured and a ratio will be calculated. A lower waist-to-hip ratio is reflective of a better body composition (less central obesity or visceral fat). | baseline, 6 months |
Eignungskriterien
Zugelassene Altersgruppen
Ältere Erwachsene
Mindestalter
65 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- aged greater than or equal to 65 years
- sedentary (Community Healthy Activities Model Program for Seniors physical activity questionnaire to identify and exclude persons engaged in regular (125 min/week or more) moderate intensity physical activity
- at risk for mobility disability score of less than or equal to 10 (but greater than 3) on the SPPB
- willing to be randomized into HE or PRT
- willing to be transported or transport themselves to the clinical sites for the intervention and assessments
- unwillingness to provide informed consent
- participation in lifestyle or pharmacologic intervention trial or structured program of exercise training in the past 6 months
- an SPPB score of less than or equal to 3
- osteoarthritis or condition with joint pain limiting daily life activities
- significant weight loss or gain (7.5% of body weight) in past six months
- current anti-coagulant or anti-platelet therapy (Coumadin, Eliquis, Pradaxa, Xarelto, heparin, Lovenox, Plavix)
- clinically significant abnormality in any of the screening laboratory values, including those identified as outside of the "normal limits', that are deemed to be of concern for participation in the study by the study physician
- acute or terminal illness
- Mini Mental State Exam (MMSE) <23
- myocardial infarction in the previous 6 months or other symptomatic coronary artery disease
- New York Heart Association Class III or IV congestive heart failure
- serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG
- chronic obstructive pulmonary disease requiring oxygen therapy
- upper or lower extremity fracture in the previous 6 months
- uncontrolled hypertension (150/90 mm Hg)
- neuromuscular diseases and/or drugs which affect neuromuscular function
- current use of anabolic steroids, growth hormone, replacement androgen therapy, anti-androgen therapy
- allergy to lidocaine
- presence of significant liver or renal disease (eGFR < 45 mL/min)
- diagnosis of type I diabetes mellitus or insulin requiring type 2 diabetes mellitus
- HbA1c > 7%
- BMI <21 or >35 for men or >40 for women
- excessive alcohol intake (>14 alcoholic beverages per wk.)
- current tobacco use
- current participation in any interventional clinical trial
- current use of weight loss medications
National Institute on Aging (NIA)
Tufts University55 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Nathan K. LeBrasseur, Hauptprüfer, Principal Investigator, Mayo Clinic
Zentrale Studienkontakte
Kontakt: Amanda Tweed, 507-255-6663, [email protected]
2 Studienstandorte in 1 Ländern
Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts, 02111, United States
Arion Mete, Kontakt, 617-556-3237, [email protected]
Roger Fielding, PhD, Hauptprüfer
Offene Rekrutierung
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States
Amanda Tweed, Kontakt, 507-255-6663, [email protected]
Nathan LeBrasseur, Ph.D, MS, Hauptprüfer
Offene Rekrutierung