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Effects of Exercise Intervention on Aging-related Motor Decline (EIAMD)

5 février 2020 mis à jour par: VA Office of Research and Development

Effects of Exercise Intervention on Aging-related Motor Decline (AGING)

The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.

Participants will be healthy adults within the target age range of 60-85 for the study. The study will require multiple visits over 15 months. There will be about 64 people volunteering for this study.

Aperçu de l'étude

Description détaillée

The U.S. Census reports over 14 million U.S. Veterans (>63%) are beyond mid-life (>55 years). Declines in upper extremity motor performance respective of strength and dexterity are well documented within this age cohort). Recent cross-sectional research has discovered that aging related motor deficits may be influenced by a loss of interhemispheric inhibition (IHI) between primary motor cortices. However, this loss may not be an inevitable consequence of aging. Work from previous VA OAA Predoctoral and CDA-1 awards have shown that aerobic fitness may serve to mitigate losses in interhemispheric inhibition assessed by both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). That is, individuals who are aerobically fit show higher levels of IHI and improved dexterity and reaction times.

In light of new evidence from the investigators' lab's recent cross-sectional studies, physical activity over the long term (at least 2-5 years) may serve to alter levels of IHI and improve motor performance in the upper extremity. Aerobic exercise may provide a mechanism (reduced loss of interhemispheric inhibition) that could serve to improve motor function, but the neural mechanism responsible for such effects remains unclear. Previous investigations of interhemispheric communication and exercise have been limited by nature of inquiry, as cross-sectional research cannot measure changes over time in participants. As such, it is currently unknown how exercise may directly affect levels of interhemispheric communication and motor performance.

Behavioral interventions (motor strength and coordination) have been shown to be effective in improving upper extremity motor performance in older adults, however the duration of these gains appear to be short-lived. After as little as a few weeks of detraining, motor strength and coordination in the upper extremity rapidly begins to return to pre-intervention levels. Evidence from exercise interventions assessing gait and locomotion have shown that exercise programs over a longer term (>6 months) are associated with improved proprioception, fewer falls and better balance. However, the comparison of outcomes of upper extremity function in elderly adults respective of exercise duration remains largely unexplored. In addition to comparing the effects of short-term exercise (3 months) versus behavioral training (3 months) on upper extremity function, the current proposal will evaluate if a longer-term (6 months) exercise program can maintain or enhance upper extremity function and associated levels of interhemispheric inhibition.

The current study proposes the next logical step in my line of research and directly investigates the effects of exercise in an intervention with sedentary older Veterans (50-80 years), a group most likely to exhibit aging-related motor deficits. The investigators propose to enroll 40 Veterans into an upper extremity dexterity improvement program involving behavioral and exercise components. The behavioral intervention is a muscle coordination training previously shown to improve unimanual motor performance in older adults. The exercise intervention is a supervised group cycling regimen. The figure below shows the study design. Interhemispheric communication will be assessed with fMRI, and TMS.

Type d'étude

Interventionnel

Inscription (Réel)

33

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

    • Georgia
      • Decatur, Georgia, États-Unis, 30033
        • Atlanta VA Medical and Rehab Center, Decatur, GA

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

60 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Living persons between 60 and 85 years of age

Exclusion Criteria:

  • unmanaged diabetes
  • participants completing vigorous exercise per week
  • participants whose profession requires vigorous physical labor
  • contraindication to magnetic resonance imaging

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: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Stretching Exercise Intervention
A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.
A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.
Expérimental: Aerobic Exercise Intervention
B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum.
Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
Expérimental: Self Monitoring Intervention
C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer.
6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Estimate Cardiovascular Efficiency After Aerobic Exercise
Délai: Baseline, 12 weeks, 24 weeks
Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.
Baseline, 12 weeks, 24 weeks
Estimate of Cardiovascular Efficiency After Balance Training
Délai: Baseline, 12 weeks, 24 weeks
Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.
Baseline, 12 weeks, 24 weeks
Silent Period Duration After Exercise Cycling Program
Délai: Baseline, 12 weeks, 24 weeks
Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds
Baseline, 12 weeks, 24 weeks
Silent Period Duration for Balance Group
Délai: Baseline, 12 weeks, 24 weeks
Ipsilateral silent period duration as assessed by TMS
Baseline, 12 weeks, 24 weeks
fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise
Délai: Baseline to 24 Weeks with cross-over
Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition.
Baseline to 24 Weeks with cross-over
fMRI Interhemispheric Inhibition Improvement After Balance Training
Délai: Baseline, 12 weeks, 24 weeks
Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition.
Baseline, 12 weeks, 24 weeks
Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention
Délai: 24 and 48 weeks
Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min).
24 and 48 weeks
Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention
Délai: 24 and 48 weeks
VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.
24 and 48 weeks
Comparison of Silent Period Duration After Aerobic Exercise
Délai: Baseline, 12 weeks, 24 weeks
Comparison of silent period duration at 24 weeks compared to baseline
Baseline, 12 weeks, 24 weeks
Comparison of Silent Period Duration After Balance Exercise
Délai: 24 and 48 weeks
Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.
24 and 48 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Target Heart Rate Zone for Balance First Participants
Délai: 24 and 48 weeks
Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve.
24 and 48 weeks
Target Heart Rate Zone After Aerobic Exercise First
Délai: 24 and 48 weeks
Targeted Heart Rate Zone among participants compared among short term exercise groups
24 and 48 weeks
Heart Rate Workload After Home Based Intervention
Délai: 24 and 48 weeks

Measured heart rate after home based intervention

Technical implementation at the facility level prevented acquisition of these metrics until late in the project.

24 and 48 weeks

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Keith M. McGregor, PhD MS BA, Atlanta VA Medical and Rehab Center, Decatur, GA

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'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)

14 janvier 2013

Achèvement primaire (Réel)

7 juillet 2018

Achèvement de l'étude (Réel)

1 août 2019

Dates d'inscription aux études

Première soumission

5 février 2013

Première soumission répondant aux critères de contrôle qualité

5 février 2013

Première publication (Estimation)

8 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 février 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 février 2020

Dernière vérification

1 février 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • E0956-W
  • 2012-060697 (Autre subvention/numéro de financement: Veterans Affairs)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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

produit fabriqué et exporté des États-Unis.

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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