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| Name | Class |
|---|---|
| Nanjing Sport Institute | UNKNOWN |
| Karolinska Institutet | OTHER |
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Aerobic exercise and resistance exercise are two types of exercise commonly used in physical conditioning. Compared to aerobic exercise, a combination of aerobic and resistance exercise has been linked to a greater reduction in hemoglobin A1c (HbA1c) among patients with type 2 diabetes (T2D). However, it is not clear that in a concurrent aerobic-resistance training session, whether the orders of the two types of exercise could act differently in glucose metabolism. This randomized trial aims to investigate the effect of the sequence of exercise modalities (aerobic-resistance vs resistance-aerobic in a training session) on glycemic control among T2D patients following an 8-wk intervention period.
Objectives:
This randomized study aims to explore the effects of aerobic and resistance training sequences on glycemic control among type 2 diabetes (T2D) patients through an 8-wk combined aerobic and resistance exercise training program.
Study Population:
A total of 56 participants with T2D aged 50-70 years (sex ratio approximately 1:1) with a course of type 2 diabetes of more than one year are included. Participants are residents of Nanjing Municipality, Jiangsu Province, China. Participants are recruited from the outpatients at Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China or through online advertisement published on the official social media (WeChat) channels of the Health Service Center.
Randomization:
Participants are stratified by baseline hemoglobin A1c (HbA1c) and age, they are randomly assigned into two groups with a block size of 4. The study groups are: 1) aerobic before resistance training (AR group, n=28); 2) resistance before aerobic training (RA group, n=28).
Exercises intervention program:
Exercised program is designed to take place three times a week for a total of eight weeks. Exercise intervention is scheduled for approximately 70 minutes per session (30 minutes of aerobic and 30 minutes of resistance, no break between two types, 5-min of preparation and 5-min relaxation stretching movements before and after each intervention), performed between 8:00 to 11:00 or between 14:00 to 16:30, Monday through Saturday.
Target heart rate during aerobic exercise is set as resting heart rate (HR) + 40%-70% of heart rate reserve (HRR). Participants' HRR was calculated based on their resting HR and maximum heart rate (HRmax=208-0.7×age) as HRmax - HR. Heart rate monitors (OH1, Polar Oy, Oulu, Finland) are used during all exercise sessions to track exercise intensity and ensure that it remained within the specified range. Aerobic exercise is performed on bicycle ergometers for a continuous 30 minutes with a progressive intensity of 40%-70% HRR. Resistance level is set according to an adaptive training prior to the first intervention, pedal cadences are 50-60r/min.
Resistance exercise is conducted using a set of equipment including chest press/ row, leg extension/ curl, abdominal/ back, biceps/ triceps, inner/ outer thigh, and push/ pull machines. Prior to conducting the 1 repetition maximum (RM) testing for the major muscles of the upper and lower limbs, all participants receive proper instructions on how to use the equipment. The Brzycki 1-RM prediction equation is used to estimate the 1RM based on the recorded resistance and repetitions. All participants performe resistance exercise with a weight of 60%-80% 1RM. Movements on each machine are repeated 10-12 times per unit for a total of 4 units, with a-30 second break between units.
In all intervention sessions, participants in AR group complete aerobic exercise before starting resistance exercise, while participants in RA group performe two types of exercise in a reversed order. Participants are instructed to maintain their usual lifestyle but refrain from engaging in other forms of regular exercise throughout the intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR group | Experimental | aerobic exercise then resistance exercise in all training sessions |
|
| RA group | Active Comparator | resistance exercise then aerobic exercise in all training sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR group: aerobic training before resistance training | Behavioral | Exercise are performed 3 times/wk for 8 wks. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve (HRR). Real-time heart rate monitors are worn by each participant during the session. Aerobic training session lasts for 30 minutes, with an additional 5-minute warm-up and 5-min relaxation training before and after the session, respectively. Participants perform resistance exercise on a set of strength training equipment. Load of resistance exercise is between 60-80% of repetition maximum (RM) in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 seconds. Between each two sets, there are 60 s of rest time. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose at Baseline | blood glucose level following overnight (12-h) fasting | At week 0, within 7 days before the intervention starts |
| Fasting Glucose at Follow-up | blood glucose level following overnight (12-h) fasting | At week 9, within 7 days after the intervention completes |
| Hemoglobin A1c (HbA1c) at Baseline | At baseline, the HbA1c level in blood among all participants | At baseline, within 7 days before the intervention starts |
| Hemoglobin A1c (HbA1c) at Follow-up | After intervention, the HbA1c level in blood among all participants | At week 9, within 7 days after the completion of the 8-week intervention |
| Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage) |
| Continuous Glucose Monitoring at Baseline (Coefficient of Variation) | At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv) |
| Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Zhao, MD, PhD | Nanjing Sport Institute | Study Director |
| Xiao Tan, PhD | Zhejiang University | Principal Investigator |
| Lijun Wei, MD | Maigaoqiao Community Health Service Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maigaoqiao Community Health Service Center | Nanjing | Jiangsu | 210000 | China |
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The exclusion criteria included patients with T1D, diseases diagnosed by physicians that are unsuitable for exercise intervention, such as severe cardiovascular diseases, acute infections, musculoskeletal disorders, and other related conditions, patients who have regular physical activity habits (90min moderate intensity exercise or 75min high intensity exercise), and currently under dietary program for weight loss
Participants were recruited in outpatient clinics or via online/printed advertisement delivered through the Maigaoqiao Community Health Service Center from Oct 1st, 2023 to Nov 3rd, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | AR Group: Aerobic Exercise Before Resistance Exercise | AR group: aerobic training before resistance training: Exercise are performed 3 times/wk for 8 wks. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve (HRR). Real-time heart rate monitors are worn by each participant during the session. Aerobic training session lasts for 30 minutes, with an additional 5-minute warm-up and 5-min relaxation training before and after the session, respectively. Participants perform resistance exercise on a set of strength training equipment. Load of resistance exercise is between 60-80% of repetition maximum (RM) in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 seconds. Between each two sets, there are 60 s of rest time. |
| FG001 | RA Group: Resistance Training Before Aerobic Training | RA group: resistance exercise before aerobic exercise: Exercise are performed 3 times/wk for 8 wks. Following a 5-min warm-up exercise, the participants perform resistance training on a set of equipment. Load of resistance exercise is set between 60-80% of repetition maximum in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 s. Between each two sets, there are 60 seconds of rest time. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve. Real-time heart rate monitors are worn during the entire session. Each aerobic training session lasts for 30 minutes, with an 5-minute relaxation training after the session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AR Group: Aerobic Exercise Before Resistance Exercise | AR group: aerobic training before resistance training: Exercise are performed 3 times/wk for 8 wks. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve (HRR). Real-time heart rate monitors are worn by each participant during the session. Aerobic training session lasts for 30 minutes, with an additional 5-minute warm-up and 5-min relaxation training before and after the session, respectively. Participants perform resistance exercise on a set of strength training equipment. Load of resistance exercise is between 60-80% of repetition maximum (RM) in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 seconds. Between each two sets, there are 60 s of rest time. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Glucose at Baseline | blood glucose level following overnight (12-h) fasting | Posted | Median | Inter-Quartile Range | mmol/L | At week 0, within 7 days before the intervention starts |
|
Baseline assessments were implemented between November 7, 2023 and November 29, 2023. Intervention was performed between November 16, 2023 and January 21, 2024. Follow-up assessments were implemented between January 2, 2024 and February 2, 2024. Adverse event data were collected until July 2, 2024. For each participant, adverse event data was collected through approximately 8 months, which was from the first date of baseline assessments to 5 months after the end of follow-up assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AR Group: Aerobic Exercise Before Resistance Exercise | AR group: aerobic training before resistance training: Exercise are performed 3 times/wk for 8 wks. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve (HRR). Real-time heart rate monitors are worn by each participant during the session. Aerobic training session lasts for 30 minutes, with an additional 5-minute warm-up and 5-min relaxation training before and after the session, respectively. Participants perform resistance exercise on a set of strength training equipment. Load of resistance exercise is between 60-80% of repetition maximum (RM) in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 seconds. Between each two sets, there are 60 s of rest time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiao Tan | Zhejiang University | 18651218270 | xiao.tan@zju.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2025 | Feb 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| RA group: resistance exercise before aerobic exercise | Behavioral | Exercise are performed 3 times/wk for 8 wks. Following a 5-min warm-up exercise, the participants perform resistance training on a set of equipment. Load of resistance exercise is set between 60-80% of repetition maximum in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 s. Between each two sets, there are 60 seconds of rest time. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve. Real-time heart rate monitors are worn during the entire session. Each aerobic training session lasts for 30 minutes, with an 5-minute relaxation training after the session. |
|
At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr |
| At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr) |
| Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | at week 8-9 |
| Continuous Glucose Monitoring at Follow-up (Coefficient of Variation) | At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR | at week 8-9 |
| Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | at week 8-9 |
| BG001 | RA Group: Resistance Training Before Aerobic Training | RA group: resistance exercise before aerobic exercise: Exercise are performed 3 times/wk for 8 wks. Following a 5-min warm-up exercise, the participants perform resistance training on a set of equipment. Load of resistance exercise is set between 60-80% of repetition maximum in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 s. Between each two sets, there are 60 seconds of rest time. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve. Real-time heart rate monitors are worn during the entire session. Each aerobic training session lasts for 30 minutes, with an 5-minute relaxation training after the session. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | RA Group: Resistance Training Before Aerobic Training | RA group: resistance exercise before aerobic exercise: Exercise are performed 3 times/wk for 8 wks. Following a 5-min warm-up exercise, the participants perform resistance training on a set of equipment. Load of resistance exercise is set between 60-80% of repetition maximum in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 s. Between each two sets, there are 60 seconds of rest time. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve. Real-time heart rate monitors are worn during the entire session. Each aerobic training session lasts for 30 minutes, with an 5-minute relaxation training after the session. |
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| Primary | Fasting Glucose at Follow-up | blood glucose level following overnight (12-h) fasting | Posted | Median | Inter-Quartile Range | mmol/L | At week 9, within 7 days after the intervention completes |
|
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| Primary | Hemoglobin A1c (HbA1c) at Baseline | At baseline, the HbA1c level in blood among all participants | Posted | Median | Inter-Quartile Range | percentage of glycated hemoglobin | At baseline, within 7 days before the intervention starts |
|
|
|
| Primary | Hemoglobin A1c (HbA1c) at Follow-up | After intervention, the HbA1c level in blood among all participants | Posted | Median | Inter-Quartile Range | percentage of glycated hemoglobin | At week 9, within 7 days after the completion of the 8-week intervention |
|
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|
| Primary | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | Posted | Mean | Standard Deviation | mmol/L | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage) |
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| Primary | Continuous Glucose Monitoring at Baseline (Coefficient of Variation) | At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR | Posted | Mean | Standard Deviation | % of relative standard deviation | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv) |
|
|
|
| Primary | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | Posted | Mean | Standard Deviation | % of measurement time | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr) |
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| Primary | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | Posted | Mean | Standard Deviation | mmol/L | at week 8-9 |
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| Primary | Continuous Glucose Monitoring at Follow-up (Coefficient of Variation) | At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR | Posted | Mean | Standard Deviation | % of relative standard deviation | at week 8-9 |
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| Primary | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr | Posted | Mean | Standard Deviation | % of measurement time | at week 8-9 |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | RA Group: Resistance Training Before Aerobic Training | RA group: resistance exercise before aerobic exercise: Exercise are performed 3 times/wk for 8 wks. Following a 5-min warm-up exercise, the participants perform resistance training on a set of equipment. Load of resistance exercise is set between 60-80% of repetition maximum in each set of exercise. Six different groups of resistance exercise (involving contractions and relaxations of biceps, triceps, pectoralis major, latissimus dorsi, quadriceps, and hamstrings) are conducted, with 6 sets of 10 repeated tasks in each group. Participants are instructed to finish each set of exercise task within 60 s. Between each two sets, there are 60 seconds of rest time. Aerobic training sessions are performed using cycle ergometers. Riding speed is 55-60 rotations/min, at an intensity between 50%-75% of heart rate reserve. Real-time heart rate monitors are worn during the entire session. Each aerobic training session lasts for 30 minutes, with an 5-minute relaxation training after the session. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D004700 | Endocrine System Diseases |
| largest amplitude of glucose excursion |
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| time below range |
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| Largest Amplitude of Glucose Excursion |
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| Time Below Range |
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