Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Resistance-type Exercise Training in the Older Population (RETO)

1. listopadu 2022 aktualizováno: Gabriel Nasri Marzuca-Nassr, Universidad de La Frontera

Comparison of the Benefits of Prolonged Resistance-type Exercise Training in the Older Population Aged 65-75 y Versus 85 y and Over

Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y).

Hypothesis: The following hypotheses will be investigated:

  • Twelve weeks of progressive resistance-type exercise training increases muscle mass and strength in young old (65-75 y) and oldest old (85 y and over) subjects.
  • The training-induced increase in muscle mass and strength is relatively greater in young old subjects when compared to oldest old subjects.

Goals: The primary aim of this study is to compare the effect of resistance-type exercise training on skeletal muscle mass (i.e. quadriceps cross-sectional area and whole body lean mass) in young old and oldest old subjects.

Specific goals

  • Determine whether resistance-type exercise training can increase muscle mass and muscle strength in young old and oldest old subjects.
  • Determine whether resistance-type exercise training can improve physical performance in young old and oldest old subjects.
  • Identify whether inflammatory markers (i.e., TNFα, IL-4, IL-6, IL-10, IL-13) are up- or down-regulated in young old and oldest old subjects before and after resistance-type exercise training.

Methodology:

Study design Sixty older females and males (young old group: n=30, 65-75 y; oldest old group: n=30, 85 y and over) will be included in this prospective clinical trial. All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 6 and 12 weeks of training, a computed tomography (CT) scan of the upper leg will be performed to assess quadriceps cross sectional area. On those days, fasting blood samples will be obtained and whole-body dual energy x-ray absorptiometry (DEXA) scan will also be performed. Maximal strength will be determined by 1-repetition maximum (1RM) and physical functioning by the short physical performance battery (SPPB) at the same time points.

Přehled studie

Detailní popis

Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y). A better understanding of the skeletal muscle adaptive response to resistance-type exercise training with advanced age will provide a strong basis to develop and implement care programs within our rapidly aging population, in which the "oldest" old represent the fastest growing group.

Hypothesis: The following hypotheses will be investigated:

  • Twelve weeks of progressive resistance-type exercise training increases muscle mass and strength in young old (65-75 y) and oldest old (85 y and over) subjects.
  • The training-induced increase in muscle mass and strength is relatively greater in young old subjects when compared to oldest old subjects.

Goals: The primary aim of this study is to compare the effect of resistance-type exercise training on skeletal muscle mass (i.e. quadriceps cross-sectional area and whole body lean mass) in young old and oldest old subjects.

Specific goals

  • Determine whether resistance-type exercise training can increase muscle mass and muscle strength in young old and oldest old subjects.
  • Determine whether resistance-type exercise training can improve physical performance in young old and oldest old subjects.
  • Identify whether inflammatory markers (i.e., TNFα, IL-4, IL-6, IL-10, IL-13) are up- or down-regulated in young old and oldest old subjects before and after resistance-type exercise training.

Methodology:

Study design Sixty older females and males (young old group: n=30, 65-75 y; oldest old group: n=30, 85 y and over) will be included in this prospective clinical trial. All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 6 and 12 weeks of training, a computed tomography (CT) scan of the upper leg will be performed to assess quadriceps cross sectional area. On those days, fasting blood samples will be obtained and whole-body dual energy x-ray absorptiometry (DEXA) scan will also be performed. Maximal strength will be determined by 1-repetition maximum (1RM) and physical functioning by the short physical performance battery (SPPB) at the same time points.

Study parameters/endpoints

  • The main study endpoint is the increase in quadriceps cross-sectional area as assessed via CT scan.
  • Secondary endpoints include: Whole-body and segmental body composition (i.e., lean mass, fat mass, bone mineral content; DEXA scan); Maximal strength assessment (1RM); Hand grip strength; Short physical performance battery (SPPB); Inflammatory and molecular markers (blood samples analysis).
  • Other study parameters include: Age, body weight, body height, body mass index (BMI), lipid profile, glucose, and insulin.

Expected results:

The impact of resistance-type exercise training to increase muscle mass and strength in the oldest old population remains unclear. With the proposed project, we expect that resistance-type exercise training will increase muscle mass and strength, although the impact will be relatively lower in the oldest old group when compared with a group of young old individuals. The potential findings will define the efficacy of resistance-type exercise training to increase muscle mass and strength in individuals with advancing age. Better maintenance, or even an increase in muscle mass and strength increases independence, prolonging good health, recovery from disease and illness, and ultimately decreases burden on healthcare systems. This information will have a beneficial impact in the exercise physiology and aging areas for future interventions at the local, regional, national and international levels.

Typ studie

Intervenční

Zápis (Aktuální)

31

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Temuco, Chile
        • Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

65 let a starší (Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Aged from 65-75 and 85 and more years.
  • 18.5 < BMI < 30 kg/m2.
  • Older people that are still "community-dwelling", i.e., not living in a nursing-home or elderly-home.

Exclusion Criteria:

  • Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
  • Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
  • All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise program (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 65 - 75 years
All volunteers aged 65 - 75 will be subjected to 12 weeks of full body resistance exercise training (3 times per week).
Všichni dobrovolníci absolvují 12 týdnů celotělového odporového cvičení (3x/týden).
Experimentální: 85 years and over
All volunteers over the age of 85 will be subjected to 12 weeks of full body resistance exercise training (3 times per week).
Všichni dobrovolníci absolvují 12 týdnů celotělového odporového cvičení (3x/týden).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in skeletal muscle mass (measured via Computed tomography (CT) scan) after prolonged resistance-type exercise training
Časové okno: Before, and after 6 and 12 weeks of training
Cross-sectional area of the quadriceps and L3 region via single-slice CT scan
Before, and after 6 and 12 weeks of training

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in lean tissue (measured via Dual Energy X-ray Absorptiometry (DEXA) scan) after prolonged resistance-type exercise training
Časové okno: Before, and after 6 and 12 weeks of training
Measurement of Whole Body Composition via DEXA
Before, and after 6 and 12 weeks of training
Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Časové okno: Before, and after 6 and 12 weeks of training
Maximal strength assessment via 1RM testing of horizontal row, lat pull down, chest press, leg press, and leg extension)
Before, and after 6 and 12 weeks of training
Change in hand grip strength (measured via JAMAR handheld dynamometer) after prolonged resistance-type exercise training
Časové okno: Before, and after 6 and 12 weeks of training
Maximal strength assessment via 1RM testing of JAMAR handheld dynamometer.
Before, and after 6 and 12 weeks of training
Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training
Časové okno: Before, and after 6 and 12 weeks of training
Measurement of physical performance via SPPB
Before, and after 6 and 12 weeks of training
Change in Inflammatory markers via ELISA after prolonged resistance-type exercise training
Časové okno: Before, and after 6 and 12 weeks of training,
Measurement in blood samples via ELISA
Before, and after 6 and 12 weeks of training,

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. června 2018

Primární dokončení (Aktuální)

8. července 2021

Dokončení studie (Aktuální)

30. října 2022

Termíny zápisu do studia

První předloženo

26. července 2021

První předloženo, které splnilo kritéria kontroly kvality

3. srpna 2021

První zveřejněno (Aktuální)

11. srpna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. listopadu 2022

Naposledy ověřeno

1. listopadu 2022

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • FONDECYT 11180949

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Odporový trénink

Předplatit