Sequences of Aerobic and Resistance Exercise and Cardio-metabolic Functions in T2D

Study Overview
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Brief Summary
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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 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.

Detailed Description
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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).

Official Title
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Sequences of Aerobic and Resistance Exercise in Training and Their Effects on Cardio-metabolic Functions Among Type 2 Diabetes Patients - a Randomized Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: AR group: aerobic training before resistance training
* Behavioral: RA group: resistance exercise before aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-72 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); 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR group: aerobic exercise before resistance exercise<br> | Behavioral: AR group: aerobic training before resistance training<br>* 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.<br>|
| Active Comparator: RA group: resistance training before aerobic training<br> | Behavioral: RA group: resistance exercise before aerobic exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose at baseline | blood glucose level following overnight (12-h) fasting | At baseline, 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 completion of the 8-week intervention | 
| Hemoglobin A1c (HbA1c) at baseline | HbA1c level in blood | At baseline, within 7 days before the intervention starts | 
| Hemoglobin A1c (HbA1c) at follow-up | HbA1c level in blood | At week 9, within 7 days after the completion of the 8-week intervention | 
| Fasting insulin at baseline | blood insulin level following overnight (12-h) fasting | At baseline, within 7 days before the intervention starts | 
| Fasting insulin at follow-up | blood insulin level following overnight (12-h) fasting | At week 9, within 7 days after the completion of the 8-week intervention | 
| Continuous glucose monitoring at baseline | 14-day continuous glucose monitoring | At baseline, within 14 days before the intervention starts, measurement lasts for 14 days | 
| Continuous glucose monitoring at follow-up | 14-day continuous glucose monitoring | At week 9-10, within 14 days after the completion of the 8-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nocturnal sleep duration and at baseline | total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA) | At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days | 
| Total nocturnal sleep duration and total awakening duration at follow-up | total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA) | At week 9-10, within 14 days after the completion of the 8-week intervention, measurement lasts for at least 7 days | 
| Insomnia Severity Index (ISI) at baseline | Insomnia Severity Index (0-28), higher score means more severe insomnia | At baseline, within 7 days before the intervention starts | 
| Insomnia Severity Index (ISI) at follow-up | Insomnia Severity Index (0-28), higher score means more severe insomnia | At week 9, within 7 days after the completion of the 8-week intervention | 
| Epworth Sleepiness Scale (ESS) at baseline | Epworth Sleepiness Scale (1-24), higher score means more sleepiness | At baseline, within 7 days before the intervention starts | 
| Epworth Sleepiness Scale (ESS) at follow-up | Epworth Sleepiness Scale (1-24), higher score means more sleepiness | At week 9, within 7 days after the completion of the 8-week intervention | 
| Berlin Questionnaire at baseline | 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. | At baseline, within 7 days before the intervention starts | 
| Berlin Questionnaire at at follow-up | 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. | At week 9, within 7 days after the completion of the 8-week intervention | 
| Diagnostic Interview for Sleep Patterns and Disorders (DISP) at baseline | Sleep patterns and disorders | At baseline, within 7 days before the intervention starts | 
| Diagnostic Interview for Sleep Patterns and Disorders (DISP) at follow-up | Sleep patterns and disorders | At week 9, within 7 days after the completion of the 8-week intervention (observation) | 
| Height at baseline | height in meters | At baseline, within 7 days before the intervention starts | 
| Height at follow-up | height in meters | At week 9, within 7 days after the completion of the 8-week intervention | 
| Weight at baseline | weight in kilograms | At baseline, within 7 days before the intervention starts | 
| Weight at follow-up | weight in kilograms | At week 9, within 7 days after the completion of the 8-week intervention (observation) | 
| K-Force measurement of static and dynamic balance at baseline | measurement of static and dynamic balance in a wide range of movements | At baseline, within 7 days before the intervention starts | 
| K-Force measurement of static and dynamic balance at follow-up | measurement of static and dynamic balance in a wide range of movements | At week 9, within 7 days after the completion of the 8-week intervention | 
| Musculoskeletal ultrasound at baseline | Quadriceps cross-sectional area and thickness | At baseline, within 7 days before the intervention starts | 
| Musculoskeletal ultrasound at follow-up | Quadriceps cross-sectional area and thickness | At week 9, within 7 days after the completion of the 8-week intervention | 
| International Physical Activity Questionnaire - Short Form at baseline | 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. | At baseline, within 7 days before the intervention starts | 
| International Physical Activity Questionnaire - Short Form at follow-up | 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. | At week 9, within 7 days after the completion of the 8-week intervention | 
| Food Frequency Questionnaire at baseline | Food frequency within 7 days | At baseline, within 7 days before the intervention starts | 
| Food Frequency Questionnaire at follow-up | Food frequency within 7 days | At week 9, within 7 days after the completion of the 8-week intervention | 
| Ambulatory Blood Pressure at baseline | 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 | At baseline, within 7 days before the intervention starts, any day within the measurement period of continuous glucose monitoring and actigraphy | 
| Ambulatory Blood Pressure at follow-up | 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 | At week 9, within 7 days before the intervention starts, any day within the measurement period of continuous glucose monitoring and actigraphy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerobic exercise, resistance exercise, exercise order, glycemic control