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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: AR group: aerobic training before resistance training; Behavioral: RA group: resistance exercise before aerobic exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Maigaoqiao Community Health Service Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR group; aerobic exercise then resistance exercise in all training sessions	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.
Active Comparator: RA group; resistance exercise then aerobic exercise in all training sessions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Karolinska Institutet; Nanjing Sport Institute
• 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 record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: aerobic exercise; resistance exercise; glycemic control; exercise order
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RT-2023-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No