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

Type 2 Diabetes Clinical Trial

— ARRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145542
• Other study ID #: RT-2023-17
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: Zhejiang University
• Contact: Xiao Tan, PhD
• Phone: +86 18651218270
• Email: xiao.tan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Maigaoqiao Community Health Service Center	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang University	Karolinska Institutet, Nanjing Sport Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose at baseline	blood glucose level following overnight (12-h) fasting	At baseline, within 7 days before the intervention starts
Primary	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
Primary	Hemoglobin A1c (HbA1c) at baseline	HbA1c level in blood	At baseline, within 7 days before the intervention starts
Primary	Hemoglobin A1c (HbA1c) at follow-up	HbA1c level in blood	At week 9, within 7 days after the completion of the 8-week intervention
Primary	Fasting insulin at baseline	blood insulin level following overnight (12-h) fasting	At baseline, within 7 days before the intervention starts
Primary	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
Primary	Continuous glucose monitoring at baseline	14-day continuous glucose monitoring	At baseline, within 14 days before the intervention starts, measurement lasts for 14 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Diagnostic Interview for Sleep Patterns and Disorders (DISP) at baseline	Sleep patterns and disorders	At baseline, within 7 days before the intervention starts
Secondary	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)
Secondary	Height at baseline	height in meters	At baseline, within 7 days before the intervention starts
Secondary	Height at follow-up	height in meters	At week 9, within 7 days after the completion of the 8-week intervention
Secondary	Weight at baseline	weight in kilograms	At baseline, within 7 days before the intervention starts
Secondary	Weight at follow-up	weight in kilograms	At week 9, within 7 days after the completion of the 8-week intervention (observation)
Secondary	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
Secondary	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
Secondary	Musculoskeletal ultrasound at baseline	Quadriceps cross-sectional area and thickness	At baseline, within 7 days before the intervention starts
Secondary	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
Secondary	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
Secondary	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
Secondary	Food Frequency Questionnaire at baseline	Food frequency within 7 days	At baseline, within 7 days before the intervention starts
Secondary	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
Secondary	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
Secondary	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