Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

1 listopada 2022 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

31

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

65 lat i starsze (Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 65 - 75 years
All volunteers aged 65 - 75 will be subjected to 12 weeks of full body resistance exercise training (3 times per week).
Wszyscy ochotnicy zostaną poddani 12 tygodniowemu treningowi siłowemu całego ciała (3x/tydz.).
Eksperymentalny: 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).
Wszyscy ochotnicy zostaną poddani 12 tygodniowemu treningowi siłowemu całego ciała (3x/tydz.).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in skeletal muscle mass (measured via Computed tomography (CT) scan) after prolonged resistance-type exercise training
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in lean tissue (measured via Dual Energy X-ray Absorptiometry (DEXA) scan) after prolonged resistance-type exercise training
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Before, and after 6 and 12 weeks of training,
Measurement in blood samples via ELISA
Before, and after 6 and 12 weeks of training,

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 czerwca 2018

Zakończenie podstawowe (Rzeczywisty)

8 lipca 2021

Ukończenie studiów (Rzeczywisty)

30 października 2022

Daty rejestracji na studia

Pierwszy przesłany

26 lipca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 sierpnia 2021

Pierwszy wysłany (Rzeczywisty)

11 sierpnia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 listopada 2022

Ostatnia weryfikacja

1 listopada 2022

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • FONDECYT 11180949

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Trening oporowy

Badania kliniczne na Przedłużony trening wysiłkowy typu oporowego

3
Subskrybuj