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

NCT ID: NCT06145542

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2024-07-02

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AR group

aerobic exercise then resistance exercise in all training sessions

Group Type: EXPERIMENTAL

AR group: aerobic training before resistance training

Intervention Type: BEHAVIORAL

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 then aerobic exercise in all training sessions

Group Type: ACTIVE_COMPARATOR

RA group: resistance exercise before aerobic exercise

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Sport Institute

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Tan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Zhao, MD, PhD

Role: STUDY_DIRECTOR

Nanjing Sport Institute

Xiao Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Lijun Wei, MD

Role: STUDY_DIRECTOR

Maigaoqiao Community Health Service Center

Locations

Maigaoqiao Community Health Service Center

Nanjing, Jiangsu, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RT-2023-17

Identifier Type: -

Identifier Source: org_study_id