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

NCT06145542 | Completed Results

• 1 other identifier: RT-2023-17
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

aerobic exercise; resistance exercise; exercise order; glycemic control

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

AR group

EXPERIMENTAL

aerobic exercise then resistance exercise in all training sessions

Behavioral: AR group: aerobic training before resistance training

RA group

ACTIVE COMPARATOR

resistance exercise then aerobic exercise in all training sessions

Behavioral: RA group: resistance exercise before aerobic exercise

Interventions

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.

AR group

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.

RA group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead
• Nanjing Sport Institute: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Maigaoqiao Community Health Service Center

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Xiao Tan
• Organization: Zhejiang University

xiao.tan@zju.edu.cn

18651218270

Study Officials

• Yan Zhao, MD, PhD

  Nanjing Sport Institute

  STUDY DIRECTOR

• Xiao Tan, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Lijun Wei, MD

  Maigaoqiao Community Health Service Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: September 25, 2023
• Primary Completion: February 2, 2024
• Study Completion: July 2, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)