Treadmill Exercise in Metabolic Syndrome
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- BIDMC
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Referred by healthcare provider and given medical clearance for moderate-intensity exercise
Metabolic syndrome, defined as meeting three or more of the following criteria:
- Obesity or overweight defined as BMI > 25
- Impaired glycemia (fasting blood sugar of ≥ 100 [5.6 mmol/L] or glycated hemoglobin [A1C] of ≥ 5.7)
- Increased blood pressure (130/85 mmHg or higher) or if you take medicine for high blood pressure
- Increased fasting levels of triglycerides (≥ 150 or 1.7 mmol/L) or decreased fasting high-density lipoprotein (HDL) cholesterol (less than 40 mg/dL or 1 mmol/L for men or 50 mg/dL or 1.3 mmol/L for women) or if you take any medicines for dyslipidemia
- Between the ages of 18-65
- No regular physical activity (≥ 3 or more days per week) for the past 3 months
Exclusion Criteria:
- Contraindications for treadmill exercise determined by their physician (e.g., cardiopulmonary limitations or diagnoses) or other inability to do treadmill exercise (e.g., musculoskeletal restrictions or severe balance impairment)
- Confirmed diagnosis of coronary artery disease
- Confirmed diagnosis of diabetes
- Currently taking a beta blocker or calcium channel blocker medication
- Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
- Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
- Self-reported psychotic disorder
- Current practice of mindfulness mediation or mindful movement (e.g., yoga or tai chi), defined as regular daily practice or >2 classes or self-guided sessions per week in the past three months.
- Non-English speaking
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Comparador Ativo: Exercício em esteira
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12-session, 6-week traditional treadmill exercise program
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Experimental: Treadmill exercise with behavioral techniques
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12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment Feasibility
Prazo: Through study completion, an average of 1 year
|
% willing to be randomized
|
Through study completion, an average of 1 year
|
|
Protocol Adherence
Prazo: Through study completion, an average of 1 year
|
% sessions attended
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Through study completion, an average of 1 year
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cardiopulmonary Dynamics
Prazo: Weeks 1 and 6
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CardioPulmonary Exercise Testing (standard metabolic cart)
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Weeks 1 and 6
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Fatigue
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Global Health
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Psychological Symptoms
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Affect
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Anxiety Sensitivity
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Distress Tolerance
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Discomfort Intolerance
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Physical Activity Acceptance
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Exercise Self-Efficacy
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Exercise Motivation
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Exercise Barriers
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Exercise Benefits and Barriers Scale; 2 subscales; Exercise benefits subscale score range: 29-116, higher scores = higher perceived benefit from exercise; Exercise barriers subscale score range: 14-56, higher scores = higher perceived barriers to exercise
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Week 0, week 3, post-intervention (after 6 week intervention)
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Physical Activity
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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Trait Mindfulness
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
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Five Facet Mindfulness Questionnaire; 5 subscales; Observe subscale score range: 8-40, higher scores = greater observing skills; Describe subscale score range: 8-40, higher scores = greater describing skills; Acting with Awareness subscale score range: 8-40, higher scores = greater awareness skills; Nonjudgment subscale score range: 8-40, higher scores = greater nonjudgment skills; Nonreactivity subscale score range: 7-35, higher scores = greater nonreactivity skills
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Week 0, week 3, post-intervention (after 6 week intervention)
|
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State Mindfulness
Prazo: Weeks 1, 3, 6
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State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
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Weeks 1, 3, 6
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Interoceptive Awareness
Prazo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- 2018P000014
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