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NCT Number: NCT06145542

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maigaoqiao Community Health Service Center

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AR group: aerobic training before resistance training

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 before aerobic exercise

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.

Primary outcomes

  1. Fasting Glucose at Baseline

    Time frame: At week 0, within 7 days before the intervention starts

    blood glucose level following overnight (12-h) fasting

  2. Fasting Glucose at Follow-up

    Time frame: At week 9, within 7 days after the intervention completes

    blood glucose level following overnight (12-h) fasting

  3. Hemoglobin A1c (HbA1c) at Baseline

    Time frame: At baseline, within 7 days before the intervention starts

    At baseline, the HbA1c level in blood among all participants

  4. Hemoglobin A1c (HbA1c) at Follow-up

    Time frame: At week 9, within 7 days after the completion of the 8-week intervention

    After intervention, the HbA1c level in blood among all participants

  5. Continuous Glucose Monitoring at Baseline (Mean, sd, Lage)

    Time frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage)

    At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

  6. Continuous Glucose Monitoring at Baseline (Coefficient of Variation)

    Time frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv)

    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

  7. Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr)

    Time frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr)

    At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

  8. Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage)

    Time frame: at week 8-9

    After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

  9. Continuous Glucose Monitoring at Follow-up (Coefficient of Variation)

    Time frame: at week 8-9

    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

  10. Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr)

    Time frame: at week 8-9

    After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Karolinska Institutet
  • Nanjing Sport Institute

Registry information

Official study title

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

Acronym: ARRA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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