Efficacy of High-intensity Exercise in Women With Prediabetes

NCT05435196 | Active Not Recruiting DMC

• 1 other identifier: CLPQ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

About 382 million of adults in the world have Diabetes type 2 (DT2), and it is foreseen that this number will increase to 592 million in 2035. International Diabetes Federation (IDF) (2017) established that 352 million adults around 20 and 79 years old (which is 7,3% of that population), could be classified as prediabetes. This last is characterized by the resistance to insulin of skeletal muscle, of the liver and/ or adipose tissue, provoking the excessive e insulin secretion of β cells and pancreatic exhaustion which produce severe hyperglycemia. The High-intensity interval training (HIIT) can increase the oxidation ability, relating directly to insulin sensibility.

Conditions

Prediabetic State

Keywords

prediabetic state; exercise therapy; women

Outcome Measures

Primary Outcomes (1)

• The glycosylated hemoglobin A1c

  To determine whether the exercise training program with intervals of high intensity, endurance and neuromuscular efficiency of large muscle groups decreases the level of glycosylated hemoglobin A1c to a greater extent than the high-intensity training program in prediabetic women, considering effective a decrease 0,17%

  24 weeks

Secondary Outcomes (3)

• The serum glucose level

  24 weeks

• The level of maximum oxygen consumption

  24 weeks

• The Visual Analog Scale

  24 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Get the training in with high-intensity interval exercise. Will be applied through 10 sets of 60 seconds. The first 30 seconds will consist of going up and down a step 15 cm high, immediately 30 seconds of squats as fast as possible with 90° knee flexion. The recovery period between each set will be 60 seconds, with a low-intensity activity (light walking). Based on high-intensity exercise, we must achieve an effort greater than 85% of the maximum frequency, using the heart rate meter and its equivalences with the Perceived Effort Scale (RPE). Receive a multimodal training that will consist of: resistance exercises for the main muscle groups of the extremities. In the plan, lumbopelvic, scapulothoracic and craniocervical neuromuscular efficiency exercises will also be included.

Other: Therapeutic exercise

Control

ACTIVE COMPARATOR

Get the training in with high-intensity interval exercise. Will be applied through 10 sets of 60 seconds. The first 30 seconds will consist of going up and down a step 15 cm high, immediately 30 seconds of squats as fast as possible with 90° knee flexion. The recovery period between each set will be 60 seconds, with a low-intensity activity (light walking). Based on high-intensity exercise, we must achieve an effort greater than 85% of the maximum frequency, using the heart rate meter and its equivalences with the Perceived Effort Scale (RPE).

Other: Therapeutic exercise

Interventions

Therapeutic exercise OTHER

The control group and the experimental group will receive the training with high-intensity interval exercise. For a period of 12 weeks both groups will participate in their exercise program, which will be supervised by the physiotherapist in charge of the study; different from the one who will carry out the randomization and the one who will perform the evaluations. Women will attend 3 times a week for an hour to the "Hospital de especialidades" to receive their exercise program in which they participated. Both groups will receive therapeutic education to encourage adherence and self-management, which include aspects such as flexibility, musculoskeletal pain, physical performance, quality of life focused on physical and mental health, etc.

Also known as: Physiotherapy

Control; Experimental

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with glycosylated hemoglobin HbA1c 39-47 mmol/mol (5.7% - 6.4%), according to the primary care registry, in the last 6 months 20,21,22.
• Women older than or equal to ≥30 to ≤60 years of age.
• To have a body mass index (BMI) greater than or equal to 25 kg/m2.
• Women who do not have any cognitive limitations to understand the information sheet and instructions, and freely sign the informed consent.

You may not qualify if:

• Uncontrolled medical problems include, but are not limited to, cardiovascular, pulmonary, rheumatological, hematological, oncological, infectious, neuromuscular, or psychiatric diseases; diabetes or another endocrine disease; immunosuppression.
• Current treatment with hormone therapy that may affect glucose metabolism.
• Current treatment with loop diuretics or thiazide diuretics.
• Current treatment with beta-blockers or peroral steroids.
• Bariatric surgery in the last 2 years.
• Women who present neuromusculoskeletal alterations that hinder or prevent the performance of the physical exercise.
• Pregnant or lactating women.
• Concomitant participation in another intervention study.

Sponsors & Collaborators

• Universidad Popular Autónoma del Estado de Puebla: lead
• Hospital de Especialidades 5 de mayo, ISSSTEP. Puebla, México: collaborator
• University of Alcala: collaborator

Study Sites (1)

UPAEP

Puebla City, 72410, Mexico

Location

Related Links

• Enhancing Exercise Responsiveness across Prediabetes Phenotypes by Targeting Insulin Sensitivity with Nutrition
• Effects of lifestyle changes on adults with prediabetes: A systematic review and meta-analysis
• Two Weeks of Interval Training Enhances Fat Oxidation during Exercise in Obese Adults with Prediabetes
• Effect of 12-Month Resistance Training on Changes in Abdominal Adipose Tissue and Metabolic Variables in Patients with Prediabetes: A Randomized Controlled Trial
• Management of prediabetes
• Prediabetes: Why Should We Care?
• High intensity, circuit-type integrated neuromuscular training alters energy balance and reduces body mass and fat in obese women: A 10-month training-detraining randomized controlled trial
• High-intensity interval neuromuscular training promotes exercise behavioral regulation, adherence and weight loss in inactive obese women
• Does low and heavy load resistance training affect musculoskeletal pain in overweight and obese women? Secondary analysis of a randomized controlled trial
• Relationships between body mass index, fat mass, muscle mass, and musculoskeletal pain in community residents
• Randomized trial assessing the impact of a musculoskeletal intervention for pain before participating in a weight management program
• Chronic pain management in the obese patient: a focused review of key challenges and potential exercise solutions
• Periodized and non-periodized resistance training programs on body composition and physical function of older women
• Time course of low- and high-volume strength training on neuromuscular adaptations and muscle quality in older women
• Eccentric Exercise to Enhance Neuromuscular Control
• Core-Muscle Training and Neuromuscular Control of the Lower Limb and Trunk
• High-Intensity Interval or Continuous Moderate Exercise: A 24-Week Pilot Trial

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• CLARA LUZ PEREZ QUIROGA, MCs

  Universidad UPAEP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Masking of the outcome variables
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: An initial evaluation, a final one, will be carried out 3 months and 6 months after the end of the study.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 28, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)