An interventional study of Combined Aerobic and Resistance Training (3:1) and Combined Aerobic and Resistance Training (1:1) in Prediabetes, sponsored by China Institute of Sport Science. Not yet recruiting at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by China Institute of Sport Science · Not applicable, Interventional, and Treatment
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.
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 212 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →China Institute of Sport Science is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Combined Aerobic and Resistance Training (3:1)
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.
Behavioral: Combined Aerobic and Resistance Training (1:1)
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.
Behavioral: Combined Aerobic and Resistance Training (1:3)
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.
Behavioral: Standardized Health Education
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.
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.
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.
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.
Glycated Hemoglobin (HbA1c) at Week 12
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.
Time frame: Week 12
Fasting Plasma Glucose at Week 12
Fasting plasma glucose will be measured from a venous blood sample after an overnight fast and reported in mmol/L.
Time frame: Week 12
2-Hour Plasma Glucose During the Oral Glucose Tolerance Test at Week 12
Plasma glucose will be measured 120 minutes after ingestion of a 75-g oral glucose load and reported in mmol/L.
Time frame: Week 12
Normal Glucose Regulation at 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.
Time frame: Week 12
Total Body Fat Percentage at Week 12
Total body fat percentage will be assessed using dual-energy X-ray absorptiometry (DXA) and reported as a percentage (%).
Time frame: Week 12
Short Physical Performance Battery Total Score at Week 12
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.
Time frame: Week 12
Matsuda Insulin Sensitivity Index at 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.
Time frame: Week 12
Glucose Coefficient of Variation From Continuous Glucose Monitoring at Week 12
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.
Time frame: 14-day monitoring period at Week 12
Moderate-to-Vigorous Physical Activity at Week 12
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.
Time frame: 7-day monitoring period at Week 12
Knee Extensor Peak Torque at 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.
Time frame: Week 12
6-Minute Walk Distance at 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.
Time frame: Week 12
Plan to share: No
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China Institute of Sport Science