Inter-individual Physiological Response to a Training and Detraining Period in Cardiometabolic Risk Factors Subjects

NCT05710653 | Completed DMC

• 1 other identifier: UNAB-FCR-KINE2023A
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Although exercise training is a well described therapy for some cardiometabolic diseases such as obesity, type 2 diabetes, arterial hypertension, and metabolic syndrome, there is scarcity of knowledge about the post-exercise period term as 'detraining' where usually all physiological adaptations as cardiovascular and metabolic benefits are lost due to physical inactivity. Likewise, as some exercise training modalities as high-intensity interval training improve vascular parameters including endothelial dysfunction parameters as flow-mediated dilation (FMD%), and carotid-intima media thickness (c-IMT) during the 'training' period, there is little knowledge about how many 'volume' or 'intensity' of exercise training or physical activity per week is needed to maintain the exercise training benefits in populations with cardiometabolic risk factors such as those patients with arterial hypertension. This information will be of great interest for both improving and maintaining the vascular profile and health of Chilean adults with risk factors and to maintain a better vascular profile. Objective: To study the beneficial adaptations from the 'training' and 'detraining' period of exercise training on functional and structural vascular parameters in healthy and cardiometabolic risk factors adult subjects to improve the health profile. Methods: The investigators will conduct an experimental design of 5 groups of exercise training in healthy (controls) and hypertensive (HTN) patients (≥140 mmHg), with overweight/or obesity, men and women, with BMI ≥25 and ≤35 kg/m2, aged ≥18y, physically inactive (\<150 min/week of low/moderate PA/week, or \<75 min/week of vigorous PA) in the last 6 months will be invited for participating. The groups will be as follows; Group (HTNex will be compared with Group HTNcg). Group (ELEex will be compared with Group ELEcg). Group (NTex will be compared with Group NTcg). Each group will be compared in their physiological vascular adaptations before and after exercise training such as HIIT, and after 3 months of a detraining period. Results (hypothesis): The investigators hypothesized that the maintenance of vascular outcomes after the 'detraining' period is intensity-dependent in adults with HTN that participated of an exercise intervention.

Conditions

Vascular Disease, Peripheral; Physical Inactivity; Arterial Hypertension; Endothelial Dysfunction

Keywords

Endothelial dysfunction; Exercise training; High-intensity interval training; Body composition; Exercise test; Obesity; Adults; Resistance training; Concurrent training

Outcome Measures

Primary Outcomes (3)

• Flow-mediated dilation in (cm)

  Change in flow-mediated dilation in the brachial artery registered by a linear transducer using images from a Doppler ultrasound

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

• Pulse wave velocity in (m/s)

  Change in pulse wave velocity in the brachial artery registered by an oscillometric cuff in the brachial artery

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

• Carotid intima media thickness in (cm)

  Change in Carotid intima media thickness in common carotid artery registered by a linear transducer using images from a Doppler ultrasound

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

Secondary Outcomes (31)

• Body mass in (kg)

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

• Height

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

• Body mass index in (kg/m2)

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

• Body fat in (%)

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

• Skeletal muscle mass in (%)

  Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up

Study Arms (6)

HTNex

EXPERIMENTAL

The participants will adhere to 12 weeks of exercise training, three times a week.

Behavioral: Exercise training intervention

HTNcg

NO INTERVENTION

These participants will maintain their normal lifestyle without intervention.

ELEex

EXPERIMENTAL

The participants will adhere to 12 weeks of exercise training, three times a week.

Behavioral: Exercise training intervention

ELEcg

NO INTERVENTION

These participants will maintain their normal lifestyle without intervention.

NTex (Control Group-exercise)

EXPERIMENTAL

The participants will adhere to 12 weeks of exercise training, three times a week.

Behavioral: Exercise training intervention

NTcg (Control Group-no exercise)

NO INTERVENTION

These participants will maintain their normal lifestyle without intervention.

Interventions

Exercise training intervention BEHAVIORAL

The intervention will consist in adhering to high-intensity interval training and/or resistance training three times a week

Also known as: Physical therapy intervention

ELEex; HTNex; NTex (Control Group-exercise)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, or subjects with elevated blood pressure (ELE) or arterial hypertension (HTN)
• ELE and/or HTN controlled or not controlled with pharmacotherapy
• With hyperglycemia, type 2 diabetes mellitus (T2DM) controlled or not controlled with pharmacotherapy
• Living in urban areas of the Concepción or Talcahuano cities
• Demonstrable ability to adhere to the exercise training programs
• To sign the written informed consent for participating in the study

You may not qualify if:

• Altered ECG
• Uncontrolled HTN (≥160 mmHg SBP, or DBP \>95 mmHg)
• Morbid obesity (≥35-40 kg/m2)
• Type 1 diabetes mellitus
• Cardiovascular disease (i.e., coronary artery disease)
• T2DM complications such as varicose ulcer in the foot, legs, or any history of the wound, nephropathies, muscle-skeletal disorders (i.e., osteoarthrosis) that could limit exercise participation, and adaptations, where ExT can be not recommended.
• Subjects under pharmacotherapy that can influence body composition such as weight- loss treatment, as well as those who are enrolled in ExT programs recently (last 3 months)

Sponsors & Collaborators

• Cristian Alvarez: lead

Study Sites (1)

Universidad Andres Bello

Talcahuano, Chile

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Sedentary Behavior; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo Araneda, PhD

  Universidad Andres Bello

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: According to availability and the feasibility of the enrolment's requirements, patients will be allocated to an arterial hypertension group (HTN), an elevated blood pressure (Ele), and a last normotensive (NT) experimental group, and thus randomly allocated to an experimental (HTNex, Eleex, NTex) or control group (HTNcg, Elecg, NTcg) in where subjetcs will not do HIIT exercise.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will compare three different exercise training experimental groups categories, such as; an arterial hypertension group (HTN), an elevated blood pressure (Ele), and a last normotensive (NT) experimental group in their physiological adaptations versus other three control groups of HTN, Ele, and NT control peers, after 3 months of training, and other 3 months od detraining y several health-related outcomes.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 2, 2023
• Study Start: June 28, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 25, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)