Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Effects of Different Aerobic-to-Resistance Training Time Ratios in Adults Aged 50 Years and Older With Prediabetes: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate how different time ratios of aerobic and resistance training affect blood glucose levels and physical health in adults aged 50 years and older with prediabetes. Researchers will compare three combined exercise programs with aerobic-to-resistance training time ratios of 3:1, 1:1, and 1:3 with a health education control group.
Participants in the exercise groups will take part in supervised training three times per week for 12 weeks. Each session will include approximately 60 minutes of aerobic and resistance exercise, with the amount of time spent on each type of exercise differing according to the assigned group. Participants will complete health assessments before and after the 12-week intervention. The main outcome of interest is glycated hemoglobin (HbA1c), which reflects average blood glucose levels over the previous 2 to 3 months. Participants in the control group will receive standardized health education and will not take part in the study-provided structured exercise program during the 12-week intervention period.
Visão geral do estudo
Status
Condições
Descrição detalhada
Prediabetes is a high-risk metabolic state associated with an increased likelihood of developing type 2 diabetes and other cardiometabolic complications. Both aerobic and resistance exercise can improve glucose regulation and metabolic health, but there is limited evidence regarding how the relative amounts of aerobic and resistance training should be combined when the overall training duration is kept similar. This study is designed to compare different aerobic-to-resistance training time ratios while maintaining a broadly comparable overall exercise duration across the exercise groups.
This is a prospective, four-arm, parallel-group randomized controlled trial. A total of 212 adults aged 50 years and older with prediabetes are planned to be randomly assigned in a 1:1:1:1 ratio to one of three combined aerobic and resistance training groups or to a health education control group. The three exercise groups will use aerobic-to-resistance training time ratios of 3:1, 1:1, and 1:3.
Participants assigned to the exercise groups will complete supervised training three times per week for 12 weeks. Each session will include approximately 60 minutes of main exercise training. The 3:1 group will complete approximately 45 minutes of aerobic exercise and 15 minutes of resistance training, the 1:1 group will complete approximately 30 minutes of each, and the 1:3 group will complete approximately 15 minutes of aerobic exercise and 45 minutes of resistance training. Aerobic training will consist of a standardized low-impact aerobic exercise routine. Resistance training will include standardized exercises targeting major muscle groups. Exercise intensity, resistance, and exercise difficulty will be progressively adjusted according to predefined training principles, safety considerations, and individual tolerance.
All study groups will receive standardized general health education. The control group will continue usual medical and community care and will not receive the study-provided structured aerobic and resistance exercise program during the 12-week intervention period.
Randomization will occur after completion of baseline assessments and confirmation of eligibility. Because of the nature of the exercise intervention, participants and exercise instructors cannot be masked to group assignment. Laboratory samples will be identified using coded study numbers without information on intervention assignment.
Study assessments will be conducted at baseline and after the 12-week intervention, with an additional follow-up planned approximately 12 weeks after completion of the intervention to explore the maintenance of selected effects. Assessments include measures of glucose regulation, body composition, physical performance, muscle strength, functional exercise capacity, physical activity, and selected metabolic measures. Continuous glucose monitoring and some additional mechanistic assessments will be conducted in prespecified exploratory components of the study.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Qi Meng
- Número de telefone: +86 17852650582
- E-mail: mengqi@ciss.cn
Locais de estudo
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Shandong
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Jining, Shandong, China
- Jining Exercise and Health Promotion Center
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Contato:
- Ming He
- Número de telefone: +86 15688833099
- E-mail: sdtyrh@shandong.cn
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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:
- Age 50 years or older.
- Body mass index (BMI) of 24.0 to 32.5 kg/m².
- Prediabetes, defined by at least one of the following: fasting plasma glucose of 5.6-6.9 mmol/L, 2-hour plasma glucose of 7.8-11.0 mmol/L during a 75-g oral glucose tolerance test, or glycated hemoglobin (HbA1c) of 5.7%-6.4%, without meeting diagnostic criteria for diabetes.
- Not regularly meeting recommended exercise levels during the previous 3 months, defined as less than 150 minutes per week of moderate-intensity aerobic activity or an equivalent amount of moderate-to-vigorous aerobic activity, and resistance training on fewer than 2 days per week.
- Able to perform activities of daily living independently and considered medically suitable to participate safely in moderate-intensity aerobic and resistance exercise.
- Able to participate in the 12-week intervention and major study assessments.
- Able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Previously diagnosed diabetes, or diabetes-range glucose results at formal baseline screening confirmed by medical assessment.
- Regular use within the previous 3 months of medications that may substantially affect glucose metabolism, body weight, or the primary outcome, including glucose-lowering medications, weight-loss medications, or systemic glucocorticoids.
- Severe, acute, or inadequately controlled medical conditions that, in the judgment of the study medical team, would make exercise participation or exercise testing unsafe.
- Severe musculoskeletal, neurological, cognitive, or psychiatric conditions that would interfere with safe participation in the intervention or study assessments.
- Alcohol Use Disorders Identification Test (AUDIT) score ≥16, or clinically significant harmful alcohol use or alcohol dependence based on medical assessment.
- Unintentional body weight change greater than 5% during the previous 6 months, or current participation in another structured intervention likely to substantially affect glucose metabolism, body weight, or physical activity.
- Pregnancy, breastfeeding, planned pregnancy during the study period, or other circumstances expected to prevent completion of the 12-week intervention and primary outcome assessment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Aerobic-to-Resistance 3:1 Training
Participants will receive 12 weeks of supervised combined aerobic and resistance training, three sessions per week. Each session will include approximately 60 minutes of main training, consisting of approximately 45 minutes of aerobic training and 15 minutes of resistance training. Participants will also receive the standardized health education provided to all study groups. |
Participants will complete 12 weeks of supervised combined aerobic and resistance training, three sessions per week. Each session will include approximately 60 minutes of main training, consisting of approximately 45 minutes of a standardized low-impact aerobic exercise routine and 15 minutes of resistance training. Training intensity and exercise difficulty will be progressively adjusted according to predefined safety criteria and individual tolerance. |
|
Experimental: Aerobic-to-Resistance 1:1 Training
Participants will receive 12 weeks of supervised combined aerobic and resistance training, three sessions per week. Each session will include approximately 60 minutes of main training, consisting of approximately 30 minutes of aerobic training and 30 minutes of resistance training. Participants will also receive the standardized health education provided to all study groups. |
Participants will complete 12 weeks of supervised combined aerobic and resistance training, three sessions per week. Each session will include approximately 60 minutes of main training, consisting of approximately 30 minutes of a standardized low-impact aerobic exercise routine and 30 minutes of resistance training. Training intensity and exercise difficulty will be progressively adjusted according to predefined safety criteria and individual tolerance. |
|
Experimental: Aerobic-to-Resistance 1:3 Training
Participants will receive 12 weeks of supervised combined aerobic and resistance training, three sessions per week. Each session will include approximately 60 minutes of main training, consisting of approximately 15 minutes of aerobic training and 45 minutes of resistance training. Participants will also receive the standardized health education provided to all study groups. |
Participants will complete 12 weeks of supervised combined aerobic and resistance training, three sessions per week. Each session will include approximately 60 minutes of main training, consisting of approximately 15 minutes of a standardized low-impact aerobic exercise routine and 45 minutes of resistance training. Training intensity and exercise difficulty will be progressively adjusted according to predefined safety criteria and individual tolerance. |
|
Comparador Ativo: Health Education Control
Participants will receive standardized health education and continue their usual medical and community care during the 12-week intervention period. They will not receive the study-provided structured aerobic or resistance exercise program during this period. |
Participants will receive standardized health education during the 12-week intervention period. The education will provide general information on prediabetes, healthy lifestyles, sleep, smoking and alcohol use, medication adherence, and health and safety. It will not include an individualized structured exercise program or an individualized weight-loss diet prescription. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Glycated Hemoglobin (HbA1c) at Week 12
Prazo: Week 12
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Glycated Hemoglobin (HbA1c) will be measured from a venous blood sample and reported as a percentage (%). The primary comparison will evaluate HbA1c at Week 12 between the randomized groups, with baseline HbA1c accounted for in the primary statistical analysis. |
Week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fasting Plasma Glucose at Week 12
Prazo: Week 12
|
Fasting plasma glucose will be measured from a venous blood sample after an overnight fast and reported in mmol/L. |
Week 12
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2-Hour Plasma Glucose During the Oral Glucose Tolerance Test at Week 12
Prazo: Week 12
|
Plasma glucose will be measured 120 minutes after ingestion of a 75-g oral glucose load and reported in mmol/L. |
Week 12
|
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Normal Glucose Regulation at Week 12
Prazo: Week 12
|
Normal glucose regulation will be defined as meeting all of the following criteria at Week 12: fasting plasma glucose <5.6 mmol/L, 2-hour plasma glucose <7.8 mmol/L during a 75-g oral glucose tolerance test, and glycated hemoglobin (HbA1c) <5.7%. The outcome will be reported as the number and proportion of participants meeting these criteria. |
Week 12
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Total Body Fat Percentage at Week 12
Prazo: Week 12
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Total body fat percentage will be assessed using dual-energy X-ray absorptiometry (DXA) and reported as a percentage (%). |
Week 12
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Short Physical Performance Battery Total Score at Week 12
Prazo: Week 12
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Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes standing balance, usual 4-meter walking speed, and five repeated chair stands. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance. |
Week 12
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Matsuda Insulin Sensitivity Index at Week 12
Prazo: Week 12
|
The Matsuda insulin sensitivity index will be calculated from glucose and insulin concentrations measured during the 75-g oral glucose tolerance test at 0, 30, 60, 90, and 120 minutes. Higher values indicate greater insulin sensitivity. |
Week 12
|
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Glucose Coefficient of Variation From Continuous Glucose Monitoring at Week 12
Prazo: 14-day monitoring period at Week 12
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Glucose variability will be assessed using the coefficient of variation derived from continuous glucose monitoring data. Continuous glucose monitoring will be conducted in a prespecified exploratory subgroup. |
14-day monitoring period at Week 12
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Moderate-to-Vigorous Physical Activity at Week 12
Prazo: 7-day monitoring period at Week 12
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Moderate-to-vigorous physical activity will be assessed objectively using an ActiGraph GT3X accelerometer and summarized as average minutes per day during valid wear days. |
7-day monitoring period at Week 12
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Knee Extensor Peak Torque at Week 12
Prazo: Week 12
|
Knee extensor strength will be assessed using isokinetic dynamometry at 60°/s. Peak torque will be recorded in N·m, with bilateral measurements obtained according to the standardized testing protocol. |
Week 12
|
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6-Minute Walk Distance at Week 12
Prazo: Week 12
|
Functional exercise capacity will be assessed using the 6-minute walk test. The primary measure will be the total distance walked in 6 minutes, reported in meters. |
Week 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Qi Meng, China Institute of Sport Science
- Diretor de estudo: Feng Qiang, PhD, China Institute of Sport Science
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Doenças Nutricionais e Metabólicas
- Estado pré-diabético
- Atividade motora
- Movimento
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Terapêutica
- Modalidades de fisioterapia
- Atendimento ao paciente
- Terapia de exercícios
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Condicionamento físico, humano
- Exercício
- Treinamento de resistência
Outros números de identificação do estudo
- CISSLA-20260714
- Project 26-05 (Número de outro subsídio/financiamento: The Fundamental Research Funds for the China Institute of Sport Science)
- Project 25-14 (Número de outro subsídio/financiamento: The Fundamental Research Funds for the China Institute of Sport Science)
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