L'impatto dei meccanismi biologici dell'invecchiamento sulla variabilità della risposta all'allenamento di resistenza negli anziani (BRIO)
L'impatto dei meccanismi biologici dell'invecchiamento sulla variabilità della risposta all'allenamento di resistenza negli anziani (BRIO): uno studio randomizzato e controllato con placebo sull'allenamento progressivo di resistenza negli anziani.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A 6-month, single blind, randomized, controlled multi-center clinical trial comparing a Health Education control intervention to a supervised Progressive Resistance Training intervention to test the central hypothesis that biological mechanisms of aging are mediators of exercise response heterogeneity in older adults.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Amanda Tweed
- Numero di telefono: 507-255-6663
- Email: tweed.amanda@mayo.edu
Luoghi di studio
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02111
- Reclutamento
- Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
-
Investigatore principale:
- Roger Fielding, PhD
-
Contatto:
- Arion Mete
- Numero di telefono: 617-556-3237
- Email: arion.mete@tufts.edu
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-
Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Reclutamento
- Mayo Clinic
-
Contatto:
- Amanda Tweed
- Numero di telefono: 507-255-6663
- Email: tweed.amanda@mayo.edu
-
Investigatore principale:
- Nathan LeBrasseur, Ph.D, MS
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Progressive Resistance Training
participants will attend exercise session 3 times per week. |
3 times a week |
|
Altro: Health Education
participants will attend health educations classed 1 time per week. |
once a week |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Precisely define the variability in changes in physical function
Lasso di tempo: baseline, 6 months
|
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
Lasso di tempo: baseline, 6 months
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Precisely define the variability in changes in skeletal muscle size.
Lasso di tempo: baseline, 6 months
|
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.
Lasso di tempo: baseline, 6 months
|
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.
Lasso di tempo: baseline, 6 months
|
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.
Lasso di tempo: baseline, 6 months
|
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.
Lasso di tempo: baseline, 6 months
|
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.
Lasso di tempo: baseline, 6 months
|
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.
Lasso di tempo: baseline, 6 months
|
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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Nathan LeBrasseur, Ph.D, MS, Mayo Clinic
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 24-010008
- R01AG089150 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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