High-intensity Interval Training for Obese Individuals

NCT04075799 | Terminated

• 1 other identifier: 07419
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal's objective is to investigate the effects of a high-intensity intermittent stair climbing program on insulin resistance in individuals with obesity and at risk of type 2 diabetes (T2D). Obesity (defined as body mass index ≥ 30kg/m2) is a major risk factor for T2D. The connection between obesity and T2D involves the development of insulin resistance (IR). Exercise training is an effective non-pharmacological approach to prevent and treat IR. Despite the efficacy of exercise training on ameliorating IR, most individuals do not achieve the minimum recommended levels of physical activity and cite "lack of time" and difficulty in accessing exercise facilities as barriers to exercise. Proposed as a time-efficient alternative, high-intensity interval training (HIIT), which consists of short periods of high-intensity efforts alternated with brief periods of recovery, is an efficient strategy to improve IR. However, most HIIT protocols have been studied in laboratory-based settings requiring access to specialized equipment (i.e. treadmills, cycle ergometers) and are not practical for the general population. The use of high-intensity intermittent stair climbing may be a suitable exercise strategy from an accessibility perspective. With evidence to suggest improvements in IR following HIIT in individuals with obesity or T2D, the application of a similar approach using high-intensity intermittent stair climbing to directly assess changes in IR in a population at risk of T2D populations is warranted. Completion of this study will help elucidate if an easy to implement, time-efficient and low-cost exercise training program improves insulin resistance in individuals at risk of T2D.

Conditions

Obesity; Insulin Resistance

Keywords

obesity; insulin resistance; high-intensity interval training

Outcome Measures

Primary Outcomes (1)

• Change in HOMA-IR concentration

  homeostasis model assessment for insulin resistance (HOMA-IR)

  Before the 8-week intervention and 72-hours after last exercise session.

Secondary Outcomes (2)

• Change in Body Composition

  After a 10-hour fast and at least 72 hours before and after the training

• Change in Maximal Oxygen Consumption

  After a 10-hour fast and at least 72 hours before and after the training

Study Arms (1)

training

EXPERIMENTAL

8 weeks using stair climbing with a frequency of thrice a week. For the first week of the stair training exercise program subjects will meet at UNM's Teaching Education Building (Stair Case 2). The following 7 weeks subjects can perform the exercise program at a staircase most convenient to them and approved by the research team. The warm-up will consist of 2 minutes of ascending and descending the stairs at a comfortable pace. The high-intensity intermittent exercise will be comprised of 6-12 x 30-seconds bout of ascending at an all-effort. A 30- seconds walking recovery will occur between the exercise bouts. After the exercise session the subject will walk during a 2-minute cool down. Every session will last between 10 to 15 minutes. The number of bouts (6-12) will be increased progressively over the weeks.

Other: high-intensity interval training

Interventions

high-intensity interval training OTHER

The HIIT protocol consists of 8 weeks using stair climbing three times per week. The warm-up will consist of 2 minutes of ascending and descending the stairs at a comfortable pace. The high-intensity intermittent exercise will comprise 6-12 x 30-seconds bouts of ascending at an all-effort. A 30- seconds walking recovery will occur between the exercise bouts. Post-exercise the subject will walk during a 2-minute cool down. Every session will last between 10 to 15 minutes. The number of bouts (6-12) will be increased progressively over the weeks. The first (week 1) and final week (week 8) of the exercise program will be monitored by a trained exercise physiologist. During supervised visits, heart rate and rating of perceived exertion (OMNI scale) will be measured at the end of each bout and after active recovery. Subjects will have the option to request further monitoring if desired.

training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years,
• body mass index (BMI) equal or superior than 30 kg/m²;
• homeostasis model assessment for insulin resistance (HOMA-IR) ≥ 2.71,
• no fear of being totally submerged underwater for 2 to 10 seconds
• comfortable having blood taken from a forearm vein.

You may not qualify if:

• smokers,
• currently taking any medications known to impact their metabolism or immune system,
• bleeding or blood clotting disorder,
• physical injury,
• physical limitations,
• diagnostic of T2D,
• currently under the active care of a physician for any condition that may interfere with their safety.
• cardiovascular conditions (cardiac, peripheral vascular, or cerebrovascular disease),
• diseases that prevent participation in a maximal effort test without physician clearance per the American College of Sports Medicine (ACSM) guidelines (2017).
• signs and symptoms of cardiovascular disease, at rest or during physical activity, which includes pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities.

Sponsors & Collaborators

• University of New Mexico: lead
• New Mexico Inbre: collaborator

Study Sites (1)

Fabiano Trigueiro Amorim

Albuquerque, New Mexico, 87110, United States

Location

Related Publications (27)

• WHO WHO. Obesity and overweight 2017

  BACKGROUND

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  PMID: 19896746 RESULT

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fabiano Amorim, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: September 3, 2019
• Study Start: January 1, 2022
• Primary Completion: April 15, 2023
• Study Completion: May 12, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)