- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02958735
Exercise and Cognition Trials (EXACT)
Human Performance: Role of Acute Exercise in Enhancing Cognitive Function
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a randomized experiment consisting of three visits for each participant. Participants are determined to be eligible beforehand during a phone screening, in which the various study inclusions and exclusions are determined and the Physical Activity Readiness Questionnaire for Everyone 2015 (PARQ) is administered.
In the first visit, various anthropometric data are collected from participants, such as height, weight, and waist and hip circumference. The participants' blood pressure is also checked for hypertension. The participants are given Dual Energy X-Ray Absorptiometry (DEXA) scans to determine total body composition (bone, fat, and fat-free mass) If the participant is female, a urine analysis to determine pregnancy is required during the visit before the DEXA to ensure safety. Participants are given the Rapid Assessment of Physical Activity (RAPA) questionnaire to assess habitual activity levels. The participants' muscle strength is also measured using the Biodex System 3, an isokinetic dynamometer. The participants then undergo a maximal stress test on a treadmill integrated with a Cardinal Health Metabolic/ECG cart using a modified Balke protocol, beginning at 3 mph, 0% grade, and increasing 2.5% grade every 3 minutes. The ECG component of the metabolic cart will be used for continuous heart rate monitoring as part of the fitness assessment. Cardiorespiratory parameters (VO2, ventilation, respiratory rate) will also be measured throughout the test. Blood pressure is measured during the last 30 seconds of each exercise stage and the rating of perceived exertion (RPE) using the Borg 6 to 20 scale is obtained during each stage. Subjects are urged to give a maximal effort and are pushed until volitional fatigue.
In the second visit, participants are first given a series of cognitive tests designed to quantify such cognitive faculties as visual short-term memory, selective attention, processing speed, and verbal fluency. These tests consist of seeing simple images on a computer screen, such as a series of colored shapes, and responding using a keypad. A blood sample is also collected from the participants to serve as a baseline. The subject is then randomized to one of three groups: the first group rests for 30 minutes; the second group walks on the treadmill at a mild intensity, defined as maintaining 60% of the heart rate observed during the max VO2 from the first visit; the last group walks on the treadmill at a hard intensity, defined as maintaining 80% of the heart rate observed during the max VO2 from the first visit. The subjects then undergo a second blood draw after cooling down, followed immediately by another round of the same cognitive tests. An hour after finishing the exercise intervention, the same procedure of blood draw followed by cognitive tests is repeated, and an hour after that it is repeated again.
The third visit must be about 24 hours after the previous visit. Participants have blood drawn and one final round of cognitive tests.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Bayview Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Body mass index (BMI) of between 18.5 and 35 kg/m2
- Normal or corrected-to-normal vision
- No contraindications to participation in moderate to hard intensity physical activity
Exclusion Criteria:
- Self-report of alcohol or substance abuse in the past year or current treatment
- Women who are pregnant or nursing
- BMI of < 18.5 or > 35 kg/m2
- Diabetes mellitus. Subjects will be excluded for diabetes even if controlled by medications
- Cigarette smoking in the previous 12 weeks
- Elevated blood pressure (BP) defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg
- Self-report of cardiovascular disease, cancer, renal disease, and other serious conditions that could be exacerbated by moderate intensity physical activity.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Rest
Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.
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Experimental: Mild Exercise
Participants randomly assigned to this arm are made to maintain a heart rate equivalent to 60% of the heart rate observed when VO2 max was achieved in the maximal stress test from the first visit.
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Participants randomized to an exercise condition will perform treadmill exercise for 30 minutes.
Participants will self-select a comfortable walking speed.
The treadmill grade will be adjusted to elicit and maintain the target heart rate.
|
|
Experimental: Hard Exercise
Participants randomly assigned to this arm are made to maintain a heart rate equivalent to 80% of the heart rate observed when VO2 max was achieved in the maximal stress test from the first visit.
|
Participants randomized to an exercise condition will perform treadmill exercise for 30 minutes.
Participants will self-select a comfortable walking speed.
The treadmill grade will be adjusted to elicit and maintain the target heart rate.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
visual short-term memory questionnaire
Prazo: baseline
|
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
|
baseline
|
|
visual short-term memory questionnaire
Prazo: up to 5 minutes post intervention
|
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
|
up to 5 minutes post intervention
|
|
visual short-term memory questionnaire
Prazo: 1 hour after intervention
|
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
|
1 hour after intervention
|
|
visual short-term memory questionnaire
Prazo: 2 hours after intervention
|
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
|
2 hours after intervention
|
|
visual short-term memory questionnaire
Prazo: 24 hours after baseline
|
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
|
24 hours after baseline
|
|
visual long-term memory questionnaire
Prazo: 24 hours after baseline
|
participants encode images in a cover task at baseline, scored on accuracy (0-100%)
|
24 hours after baseline
|
|
verbal fluency
Prazo: baseline
|
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
|
baseline
|
|
verbal fluency
Prazo: up to 5 minutes post intervention
|
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
|
up to 5 minutes post intervention
|
|
verbal fluency
Prazo: 1 hour after intervention
|
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
|
1 hour after intervention
|
|
verbal fluency
Prazo: 2 hours after intervention
|
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
|
2 hours after intervention
|
|
verbal fluency
Prazo: 24 hours after baseline
|
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
|
24 hours after baseline
|
|
cortisol in circulation
Prazo: baseline
|
in nanograms per milliliter (ng/ml)
|
baseline
|
|
cortisol in circulation
Prazo: up to 5 minutes post intervention
|
in nanograms per milliliter (ng/ml)
|
up to 5 minutes post intervention
|
|
cortisol in circulation
Prazo: 1 hour after intervention
|
in nanograms per milliliter (ng/ml)
|
1 hour after intervention
|
|
cortisol in circulation
Prazo: 2 hours after intervention
|
in nanograms per milliliter (ng/ml)
|
2 hours after intervention
|
|
cortisol in circulation
Prazo: 24 hours after baseline
|
in nanograms per milliliter (ng/ml)
|
24 hours after baseline
|
|
igf-1 in circulation
Prazo: baseline
|
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
baseline
|
|
igf-1 in circulation
Prazo: up to 5 minutes post intervention
|
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
up to 5 minutes post intervention
|
|
igf-1 in circulation
Prazo: 1 hour after intervention
|
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
1 hour after intervention
|
|
igf-1 in circulation
Prazo: 2 hours after intervention
|
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
2 hours after intervention
|
|
igf-1 in circulation
Prazo: 24 hours after baseline
|
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
24 hours after baseline
|
|
bdnf in circulation
Prazo: baseline
|
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
baseline
|
|
bdnf in circulation
Prazo: up to 5 minutes post intervention
|
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
up to 5 minutes post intervention
|
|
bdnf in circulation
Prazo: 1 hour after intervention
|
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
1 hour after intervention
|
|
bdnf in circulation
Prazo: 2 hours after intervention
|
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
2 hours after intervention
|
|
bdnf in circulation
Prazo: 24 hours after baseline
|
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
24 hours after baseline
|
|
general executive functioning as assessed by the stroop test questionnaire
Prazo: baseline
|
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
|
baseline
|
|
general executive functioning as assessed by the stroop test questionnaire
Prazo: up to 5 minutes post intervention
|
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
|
up to 5 minutes post intervention
|
|
general executive functioning as assessed by the stroop test questionnaire
Prazo: 1 hour after intervention
|
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
|
1 hour after intervention
|
|
general executive functioning as assessed by the stroop test questionnaire
Prazo: 2 hours after intervention
|
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
|
2 hours after intervention
|
|
general executive functioning as assessed by the stroop test questionnaire
Prazo: 24 hours after baseline
|
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
|
24 hours after baseline
|
|
general executive functioning as assessed by the flanker task questionnaire
Prazo: baseline
|
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
baseline
|
|
general executive functioning as assessed by the flanker task questionnaire
Prazo: up to 5 minutes post intervention
|
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
up to 5 minutes post intervention
|
|
general executive functioning as assessed by the flanker task questionnaire
Prazo: 1 hour after intervention
|
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
1 hour after intervention
|
|
general executive functioning as assessed by the flanker task questionnaire
Prazo: 2 hours after intervention
|
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
2 hours after intervention
|
|
general executive functioning as assessed by the flanker task questionnaire
Prazo: 24 hours after baseline
|
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
24 hours after baseline
|
|
general executive functioning as assessed by the irrelevant capture task questionnaire
Prazo: baseline
|
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
baseline
|
|
general executive functioning as assessed by the irrelevant capture task questionnaire
Prazo: up to 5 minutes post intervention
|
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
up to 5 minutes post intervention
|
|
general executive functioning as assessed by the irrelevant capture task questionnaire
Prazo: 1 hour after intervention
|
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
1 hour after intervention
|
|
general executive functioning as assessed by the irrelevant capture task questionnaire
Prazo: 2 hours after intervention
|
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
2 hours after intervention
|
|
general executive functioning as assessed by the irrelevant capture task questionnaire
Prazo: 24 hours after baseline
|
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
|
24 hours after baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
total and regional bone mass
Prazo: baseline
|
as assessed by dual-energy x-ray absorptiometry (DEXA) scan, in grams per square centimeter (g/cm2)
|
baseline
|
|
total and regional fat and fat-free mass
Prazo: baseline
|
as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)
|
baseline
|
|
habitual activity levels
Prazo: baseline
|
as assessed by Rapid Assessment of Physical Activity questionnaire, possible scores are: Active, Under Active Regular, Under Active Regular- Light Activities, Under Active, Sedentary
|
baseline
|
|
muscle strength
Prazo: baseline
|
as measured by isokinetic testing using the Biodex System 3
|
baseline
|
|
cardiorespiratory endurance
Prazo: baseline
|
as assessed by maximal stress test, represented by heart rate at maximal oxygen uptake
|
baseline
|
|
body mass index (BMI)
Prazo: baseline
|
measured in kilograms per square meter (kg/m2)
|
baseline
|
|
waist-to-hip ratio
Prazo: baseline
|
baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Peter Searson, PhD, Johns Hopkins University
- Investigador principal: Kerry Stewart, EdD, Johns Hopkins University
- Investigador principal: Howard Egeth, PhD, Johns Hopkins University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- IRB00076336
Plano para dados de participantes individuais (IPD)
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