Type 2 Diabetes
Conditions
Keywords
aerobic exercise, resistance exercise, exercise order, glycemic control
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAR 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.
BEHAVIORALRA 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.
Sponsors
Nanjing Sport Institute
Karolinska Institutet
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 50-70 years; * Type 2 diabetes diagnosed as: random blood glucose ≥11.1mmol/L (200mg/dL) or fasting blood glucose ≥7.0mmol/L (126mg/L) or oral glucose tolerance test (2h) ≥11.1mmol/L (200mg/dL) or glycated hemoglobin (HbA1c) ≥ 6.5%; * The course of type 2 diabetes lasted for one year or longer; * Willing to participate and sign the informed consent form voluntarily
Exclusion criteria
* Type 1 diabetes; * Fasting blood glucose (FBG)\>16.7mmol/L; * Severe complications of diabetes such as acute infection, diabetic ketoacidosis, and plantar lesions; * Severe kidney disease, cardiovascular and cerebrovascular diseases as identified by a specialist; * Musculoskeletal, neurological, psychiatric or other disorders which limit the ability to exercise as identified by a specialist; * Doing physical exercise regularly (≥ 3 times per week, at least 1 hour per session of moderate to vigorous activities); * Currently under dietary program for weight loss; * Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at rest; * Abnormal electrocardiogram (rest and exercise); * Other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose at Baseline | At week 0, within 7 days before the intervention starts | blood glucose level following overnight (12-h) fasting |
| Fasting Glucose at Follow-up | At week 9, within 7 days after the intervention completes | blood glucose level following overnight (12-h) fasting |
| Hemoglobin A1c (HbA1c) at Baseline | At baseline, within 7 days before the intervention starts | At baseline, the HbA1c level in blood among all participants |
| Hemoglobin A1c (HbA1c) at Follow-up | At week 9, within 7 days after the completion of the 8-week intervention | After intervention, the HbA1c level in blood among all participants |
| Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage) | At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr |
| Continuous Glucose Monitoring at Baseline (Coefficient of Variation) | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv) | 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 |
| Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr) | At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr |
| Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | at week 8-9 | After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr |
| Continuous Glucose Monitoring at Follow-up (Coefficient of Variation) | at week 8-9 | 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 |
| Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | at week 8-9 | After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | RA Group: Resistance Training Before Aerobic Training | Total | AR Group: Aerobic Exercise Before Resistance Exercise |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 4.5 | 62.5 years STANDARD_DEVIATION 4.3 | 61.7 years STANDARD_DEVIATION 4.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 28 participants | 56 participants | 28 participants |
| Sex: Female, Male Female | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
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
Time frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Coefficient of Variation) | 24.1 % of relative standard deviation | Standard Deviation 5.6 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Coefficient of Variation) | 25.1 % of relative standard deviation | Standard Deviation 3.9 |
Primary
Continuous Glucose Monitoring at Baseline (Mean, sd, Lage)
At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr
Time frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | mean glucose | 8.7 mmol/L | Standard Deviation 1.3 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | standard deviation of blood glucose | 2.2 mmol/L | Standard Deviation 0.7 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | largest amplitude of glucose excursion | 8.7 mmol/L | Standard Deviation 1.9 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | mean glucose | 8.1 mmol/L | Standard Deviation 1.5 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | standard deviation of blood glucose | 2.1 mmol/L | Standard Deviation 0.6 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Mean, sd, Lage) | largest amplitude of glucose excursion | 8.3 mmol/L | Standard Deviation 1.9 |
Primary
Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr)
At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr
Time frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | time in range | 72.3 % of measurement time | Standard Deviation 18.8 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | time above range | 33.6 % of measurement time | Standard Deviation 26.4 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | time below range | 0.4 % of measurement time | Standard Deviation 1.1 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | time in range | 77.4 % of measurement time | Standard Deviation 16.7 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | time above range | 23.9 % of measurement time | Standard Deviation 20.7 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr) | time below range | 0.9 % of measurement time | Standard Deviation 2.1 |
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
Time frame: at week 8-9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Coefficient of Variation) | 26.1 % of relative standard deviation | Standard Deviation 4.4 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Coefficient of Variation) | 25.6 % of relative standard deviation | Standard Deviation 4.2 |
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
Time frame: at week 8-9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | Mean Glucose | 8.2 mmol/L | Standard Deviation 1 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | Standard Deviation of Blood Glucose | 2.4 mmol/L | Standard Deviation 0.7 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | Largest Amplitude of Glucose Excursion | 9.1 mmol/L | Standard Deviation 2.2 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | Mean Glucose | 8.4 mmol/L | Standard Deviation 1.6 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | Standard Deviation of Blood Glucose | 2.1 mmol/L | Standard Deviation 0.5 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage) | Largest Amplitude of Glucose Excursion | 8.1 mmol/L | Standard Deviation 1.5 |
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
Time frame: at week 8-9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | Time In Range | 75.9 % of measurement time | Standard Deviation 12.9 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | Time Above Range | 27.6 % of measurement time | Standard Deviation 21.6 |
| AR Group: Aerobic Exercise Before Resistance Exercise | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | Time Below Range | 1.4 % of measurement time | Standard Deviation 4.3 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | Time In Range | 78.0 % of measurement time | Standard Deviation 13.9 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | Time Above Range | 26.1 % of measurement time | Standard Deviation 20.6 |
| RA Group: Resistance Training Before Aerobic Training | Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr) | Time Below Range | 0.9 % of measurement time | Standard Deviation 2.1 |
Primary
Fasting Glucose at Baseline
blood glucose level following overnight (12-h) fasting
Time frame: At week 0, within 7 days before the intervention starts
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Fasting Glucose at Baseline | 7.2 mmol/L |
| RA Group: Resistance Training Before Aerobic Training | Fasting Glucose at Baseline | 7.0 mmol/L |
Primary
Fasting Glucose at Follow-up
blood glucose level following overnight (12-h) fasting
Time frame: At week 9, within 7 days after the intervention completes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Fasting Glucose at Follow-up | 7.2 mmol/L |
| RA Group: Resistance Training Before Aerobic Training | Fasting Glucose at Follow-up | 7.4 mmol/L |
Primary
Hemoglobin A1c (HbA1c) at Baseline
At baseline, the HbA1c level in blood among all participants
Time frame: At baseline, within 7 days before the intervention starts
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Hemoglobin A1c (HbA1c) at Baseline | 7.5 percentage of glycated hemoglobin |
| RA Group: Resistance Training Before Aerobic Training | Hemoglobin A1c (HbA1c) at Baseline | 7.3 percentage of glycated hemoglobin |
Primary
Hemoglobin A1c (HbA1c) at Follow-up
After intervention, the HbA1c level in blood among all participants
Time frame: At week 9, within 7 days after the completion of the 8-week intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AR Group: Aerobic Exercise Before Resistance Exercise | Hemoglobin A1c (HbA1c) at Follow-up | 7.0 percentage of glycated hemoglobin |
| RA Group: Resistance Training Before Aerobic Training | Hemoglobin A1c (HbA1c) at Follow-up | 7.2 percentage of glycated hemoglobin |