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Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes

30 oktober 2026 bijgewerkt door: China Institute of Sport Science

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

212

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Qi Meng
  • Telefoonnummer: +86 17852650582
  • E-mail: mengqi@ciss.cn

Studie Locaties

  • China
    • Shandong
      • Jining, Shandong, China
        • Jining Exercise and Health Promotion Center
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Combined Aerobic and Resistance Training (3:1)

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.
Experimenteel: 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.
Gedragsmatig: Combined Aerobic and Resistance Training (1:1)

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.
Experimenteel: 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.
Gedragsmatig: Combined Aerobic and Resistance Training (1:3)

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.
Actieve vergelijker: 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.
Gedragsmatig: Standardized Health Education

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glycated Hemoglobin (HbA1c) at Week 12
Tijdsspanne: 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.
Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fasting Plasma Glucose at Week 12
Tijdsspanne: Week 12

Fasting plasma glucose will be measured from a venous blood sample after an overnight fast and reported in mmol/L.
Week 12
2-Hour Plasma Glucose During the Oral Glucose Tolerance Test at Week 12
Tijdsspanne: 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
Normal Glucose Regulation at Week 12
Tijdsspanne: 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
Total Body Fat Percentage at Week 12
Tijdsspanne: Week 12

Total body fat percentage will be assessed using dual-energy X-ray absorptiometry (DXA) and reported as a percentage (%).
Week 12
Short Physical Performance Battery Total Score at Week 12
Tijdsspanne: 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.
Week 12

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Matsuda Insulin Sensitivity Index at Week 12
Tijdsspanne: 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
Glucose Coefficient of Variation From Continuous Glucose Monitoring at Week 12
Tijdsspanne: 14-day monitoring period 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.
14-day monitoring period at Week 12
Moderate-to-Vigorous Physical Activity at Week 12
Tijdsspanne: 7-day monitoring period 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.
7-day monitoring period at Week 12
Knee Extensor Peak Torque at Week 12
Tijdsspanne: 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
6-Minute Walk Distance at Week 12
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China Institute of Sport Science

Onderzoekers

  • Hoofdonderzoeker: Qi Meng, China Institute of Sport Science
  • Studie directeur: Feng Qiang, PhD, China Institute of Sport Science

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

23 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 oktober 2026

Eerst geplaatst (Werkelijk)

29 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CISSLA-20260714
  • Project 26-05 (Ander subsidie-/financieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)
  • Project 25-14 (Ander subsidie-/financieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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