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

1 novembre 2022 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

31

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 65 - 75 years
All volunteers aged 65 - 75 will be subjected to 12 weeks of full body resistance exercise training (3 times per week).
Tous les volontaires seront soumis à 12 semaines d'exercices de type résistance du corps entier (3x/semaine).
Expérimental: 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).
Tous les volontaires seront soumis à 12 semaines d'exercices de type résistance du corps entier (3x/semaine).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in skeletal muscle mass (measured via Computed tomography (CT) scan) after prolonged resistance-type exercise training
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in lean tissue (measured via Dual Energy X-ray Absorptiometry (DEXA) scan) after prolonged resistance-type exercise training
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Before, and after 6 and 12 weeks of training,
Measurement in blood samples via ELISA
Before, and after 6 and 12 weeks of training,

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juin 2018

Achèvement primaire (Réel)

8 juillet 2021

Achèvement de l'étude (Réel)

30 octobre 2022

Dates d'inscription aux études

Première soumission

26 juillet 2021

Première soumission répondant aux critères de contrôle qualité

3 août 2021

Première publication (Réel)

11 août 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 novembre 2022

Dernière vérification

1 novembre 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • FONDECYT 11180949

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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