NCT05580263

Brief Summary

Purposes: The purpose of one-year project is to compare the effect of different intrasession exercise order of AE and RE during concurrent training on reducing VAT and improving insulin resistance for inactive middle-age community residents with obesity. Methods: Purposive sampling will be used to enroll community residents aged 40-64 years with inactive habit and body fat percentage ≧ 25% for male and ≧ 30% for female in southern Taiwan. Eligible participants will be stratified by sex and age (40-55years and 56-64 years) then block randomly divided into training group of AE preceding RE, RE preceding AE or a control group. The exercise training program will under supervision lasting 16 weeks with 3 times per week. The concurrent training prescription consist of AE 30 minutes and RE 15 minutes per session. A 5-minute interval between two exercise modalities. All participants will be evaluated outcomes for two time points including baseline (T0) and after 16-week intervention (T1). The primary outcomes are VAT and insulin resistance. A two-way ANOVA with repeated measures will be performed to compare changes of outcome variables over the intervention period. Relevance to clinical practice: The results of this project can assist health professionals to know how to properly prescribe concurrent training of AE and RE to achieve the greatest effects on VATreduction and insulin resistance improvement for middle-age residents with obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

October 3, 2022

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • visceral adipose tissue

    Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.

    at baseline

  • visceral adipose tissue

    Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.

    16-week after intervention

  • Insulin

    Participants will collect insulin at baseline by blood samples

    at baseline

  • Insulin

    Participants will collect insulin after 16-week intervention by blood samples

    16-week after intervention

  • Fasting glucose

    Participants will collect fasting glucose at baseline by blood samples

    at baseline

  • Fasting glucose

    Participants will collect fasting glucose after 16-week intervention by blood samples

    16-week after intervention

Secondary Outcomes (8)

  • waist circumference

    at baseline

  • waist circumference

    16-week after intervention

  • hip circumference

    at baseline

  • hip circumference

    16-week after intervention

  • weight

    at baseline

  • +3 more secondary outcomes

Study Arms (3)

aerobic exercise(AE) preceding resistance exercise(RE)

EXPERIMENTAL

at least moderate intensity of AE 30 minutes than RE 15 minutes, with a break of 5 minutes between two modalities of training.

Behavioral: aerobic exerciseBehavioral: resistance exercise

RE preceding AE

EXPERIMENTAL

RE 15 minutes than at least moderate intensity of AE 30 minutes, with a break of 5 minutes between two modalities of training.

Behavioral: aerobic exerciseBehavioral: resistance exercise

Control group

NO INTERVENTION

Participants maintain their usual life without any exercise intervention.

Interventions

The main AE program will be designed and controlled for at least moderate intensity of heart rate reserve (HRR) lasting 30 minutes. The goal of intensity will be set at least 40% of HRR during the first two weeks, and then progressively increase the targeted intensity at the end of 16 weeks with 60% HRR. The motions will design by involving core muscle training (e.g., march, step touch, lunge, V-step, box step, twist, knee up, scoop, and scissors).

RE preceding AEaerobic exercise(AE) preceding resistance exercise(RE)

In the process, the participants will be instructed by resisting the weight smoothly, and peaking at hold. RE prescription consist of 2-4 sets with 10-15 repetitions per set with a rest interval of 1-2 minutes between sets to improve muscular fitness. The first two weeks will start with two sets of 10-15 repetitions and then gradually progress on four sets of 15 repetitions at the end of 16 weeks. The total duration of RE will lasting around 15 minutes.

RE preceding AEaerobic exercise(AE) preceding resistance exercise(RE)

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 64 years old.
  • body fat percentage ≧ 25% for male and ≧ 30% for female.
  • with inactive habit (≤ 3 days of physical activity per week and ≤ 30 min per session).
  • can communicate in Mandarin or Taiwanese.

You may not qualify if:

  • with recent unstable conditions in which had potential risk on exercise including stroke, cardiovascular and respiratory diseases, handicap, pregnancy.
  • with any contraindications to body composition analyzer measurement including body embed pacemakers and artificial metal joints, amputated hands or feet.
  • cannot corporate with either examination or intervention.
  • use psychotropic or appetite-regulating medicine.
  • under oral hopoglycemic agent or insulin treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natioal Tainan Junior College of Nursing

Tainan, 700, Taiwan

Location

MeSH Terms

Interventions

ExerciseResistance Training

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Yu-Hsuan Chang, phD

    National Tainan Junior College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
PI (data assessor) will be blinded for the grouping.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 14, 2022

Study Start

October 31, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Data available on request due to privacy/ethical restrictions

Locations