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Type 2 DiabetesARRANCT06145542

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

A study testing AR group: aerobic training before resistance training and RA group: resistance exercise before aerobic exercise in people with Type 2 Diabetes, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
AR group: aerobic training before resistance training and RA group: resistance exercise before aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
25 Sep 2023to 2 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Maigaoqiao Community Health Service Center

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

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.

Read the 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
Being tested
AR group: aerobic training before resistance training, RA group: resistance exercise before aerobic exercise
Keywords
aerobic exercise, resistance exercise, exercise order, glycemic control
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AR group: aerobic training before resistance trainingBehavioural

    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 exerciseBehavioural

    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.

Study groups in NCT06145542
Study groupRoleWhat they receive
AR groupExperimentalaerobic exercise then resistance exercise in all training sessions
Receives: Behavioral: AR group: aerobic training before resistance training
RA groupActive comparatorresistance exercise then aerobic exercise in all training sessions
Receives: Behavioral: RA group: resistance exercise before aerobic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting Glucose at Baseline

    blood glucose level following overnight (12-h) fasting

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

  2. Fasting Glucose at Follow-up

    blood glucose level following overnight (12-h) fasting

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

  3. Hemoglobin A1c (HbA1c) at Baseline

    At baseline, the HbA1c level in blood among all participants

    Measured: At baseline, within 7 days before the intervention starts

  4. Hemoglobin A1c (HbA1c) at Follow-up

    After intervention, the HbA1c level in blood among all participants

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

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

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

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

  6. 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

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

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

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

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

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

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

    Measured: at week 8-9

  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

    Measured: at week 8-9

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

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

    Measured: at week 8-9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2023
  2. Study start25 Sep 2023
  3. Primary completion2 Feb 2024
  4. Study completion2 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06145542
Sponsor's protocol ID
RT-2023-17
Acronym
ARRA
Status last verified
Apr 2025
First submitted
17 Nov 2023
Last updated
3 Apr 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AR group: aerobic training before resistance training and RA group: resistance exercise before aerobic exercise in people with Type 2 Diabetes, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Glucose at Baseline (time frame: At week 0, within 7 days before the intervention starts). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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