ARRA: Sequences of Aerobic and Resistance Exercise and Cardio-metabolic Functions in T2D
Study Details
Study Description
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 pilot 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. The trial also aims to compare the effects of the two different sequences in blood pressure, sleep quality, and lower limb muscle strength among the T2D population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Objectives:
This pilot 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. The secondary objectives are to compare the effects of different training sequences on blood pressure, sleep quality, and lower limb muscle strength in type 2 diabetes over the 8-wk intervention period.
Study Population:
A total of 60 participants with T2D aged 40-70 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 through printed advertisement delivered at Maigaoqiao Community Health Service Center, Qixia District, Nanjing, or via 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 six. The study groups are: 1) aerobic before resistance training (AR group, n=30); 2) resistance before aerobic training (RA group, n=30).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AR group: aerobic exercise before resistance exercise
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Behavioral: 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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| Active Comparator: RA group: resistance training before aerobic training
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Behavioral: 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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Outcome Measures
Primary Outcome Measures
- Fasting glucose at baseline [At baseline, 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 completion of the 8-week intervention]
blood glucose level following overnight (12-h) fasting
- Hemoglobin A1c (HbA1c) at baseline [At baseline, within 7 days before the intervention starts]
HbA1c level in blood
- Hemoglobin A1c (HbA1c) at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
HbA1c level in blood
- Fasting insulin at baseline [At baseline, within 7 days before the intervention starts]
blood insulin level following overnight (12-h) fasting
- Fasting insulin at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
blood insulin level following overnight (12-h) fasting
- Continuous glucose monitoring at baseline [At baseline, within 14 days before the intervention starts, measurement lasts for 14 days]
14-day continuous glucose monitoring
- Continuous glucose monitoring at follow-up [At week 9-10, within 14 days after the completion of the 8-week intervention]
14-day continuous glucose monitoring
Secondary Outcome Measures
- Total nocturnal sleep duration and at baseline [At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days]
total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA)
- Total nocturnal sleep duration and total awakening duration at follow-up [At week 9-10, within 14 days after the completion of the 8-week intervention, measurement lasts for at least 7 days]
total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA)
- Insomnia Severity Index (ISI) at baseline [At baseline, within 7 days before the intervention starts]
Insomnia Severity Index (0-28), higher score means more severe insomnia
- Insomnia Severity Index (ISI) at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
Insomnia Severity Index (0-28), higher score means more severe insomnia
- Epworth Sleepiness Scale (ESS) at baseline [At baseline, within 7 days before the intervention starts]
Epworth Sleepiness Scale (1-24), higher score means more sleepiness
- Epworth Sleepiness Scale (ESS) at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
Epworth Sleepiness Scale (1-24), higher score means more sleepiness
- Berlin Questionnaire at baseline [At baseline, within 7 days before the intervention starts]
High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
- Berlin Questionnaire at at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
- Diagnostic Interview for Sleep Patterns and Disorders (DISP) at baseline [At baseline, within 7 days before the intervention starts]
Sleep patterns and disorders
- Diagnostic Interview for Sleep Patterns and Disorders (DISP) at follow-up [At week 9, within 7 days after the completion of the 8-week intervention (observation)]
Sleep patterns and disorders
- Height at baseline [At baseline, within 7 days before the intervention starts]
height in meters
- Height at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
height in meters
- Weight at baseline [At baseline, within 7 days before the intervention starts]
weight in kilograms
- Weight at follow-up [At week 9, within 7 days after the completion of the 8-week intervention (observation)]
weight in kilograms
- K-Force measurement of static and dynamic balance at baseline [At baseline, within 7 days before the intervention starts]
measurement of static and dynamic balance in a wide range of movements
- K-Force measurement of static and dynamic balance at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
measurement of static and dynamic balance in a wide range of movements
- Musculoskeletal ultrasound at baseline [At baseline, within 7 days before the intervention starts]
Quadriceps cross-sectional area and thickness
- Musculoskeletal ultrasound at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
Quadriceps cross-sectional area and thickness
- International Physical Activity Questionnaire - Short Form at baseline [At baseline, within 7 days before the intervention starts]
International Physical Activity Questionnaire (IPAQ) - Short Form for assessing level of physical activity. Level of physical activity are calculated into metabolic equivalent minutes per week (MET mins/wk) according to the answers of the questionnaire. Higher MET mins/wk refers to higher level of physical activity.
- International Physical Activity Questionnaire - Short Form at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
International Physical Activity Questionnaire (IPAQ) - Short Form for assessing level of physical activity. Level of physical activity are calculated into metabolic equivalent minutes per week (MET mins/wk) according to the answers of the questionnaire. Higher MET mins/wk refers to higher level of physical activity.
- Food Frequency Questionnaire at baseline [At baseline, within 7 days before the intervention starts]
Food frequency within 7 days
- Food Frequency Questionnaire at follow-up [At week 9, within 7 days after the completion of the 8-week intervention]
Food frequency within 7 days
- Ambulatory Blood Pressure at baseline [At baseline, within 7 days before the intervention starts, any day within the measurement period of continuous glucose monitoring and actigraphy]
Repeated measurement of blood pressure every 30 mins over a 24-h period, device attached on participant's waist with a cuff attached to the left upper arm
- Ambulatory Blood Pressure at follow-up [At week 9, within 7 days before the intervention starts, any day within the measurement period of continuous glucose monitoring and actigraphy]
Repeated measurement of blood pressure every 30 mins over a 24-h period, device attached on participant's waist with a cuff attached to the left upper arm
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 40-72 years;
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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%;
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The course of type 2 diabetes lasted for one year or longer;
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Willing to participate and sign the informed consent form voluntarily
Exclusion Criteria:
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Type 1 diabetes;
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Fasting blood glucose (FBG)>16.7mmol/L;
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Severe complications of diabetes such as acute infection, diabetic ketoacidosis, and plantar lesions;
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Severe kidney disease, cardiovascular and cerebrovascular diseases as identified by a specialist;
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Musculoskeletal, neurological, psychiatric or other disorders which limit the ability to exercise as identified by a specialist;
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Doing physical exercise regularly (≥ 3 times per week, at least 1 hour per session of moderate to vigorous activities);
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Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at rest;
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Abnormal electrocardiogram (rest and exercise);
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Other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maigaoqiao Community Health Service Center | Nanjing | Jiangsu | China | 210000 |
Sponsors and Collaborators
- Zhejiang University
- Nanjing Sport Institute
- Karolinska Institutet
Investigators
- Study Director: Yan Zhao, MD, PhD, Nanjing Sport Institute
- Principal Investigator: Xiao Tan, PhD, Zhejiang University
- Study Director: Lijun Wei, MD, Maigaoqiao Community Health Service Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RT-2023-17