Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05435196 |
| Other study ID # |
CLPQ |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Universidad Popular Autónoma del Estado de Puebla |
| Contact |
CLARA LUZ PEREZ QUIROGA, MCs |
| Phone |
2222299400 |
| Email |
claraluz.perez[@]upaep.mx |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
According to the latest research of the International Diabetes Federation (IDF) (2017), 352
million of adults around 20 and 79 years old (which is 7,3% of that population), could be
classified as prediabetes. It is foreseen that this number will increase to 481 million in
2040. People with prediabetes have approximately 30% of the possibility to develop diabetes
mellitus type 2 (DM2) during a term of 10 years. Prediabetes is characterized by levels of
glucose in blood above the normal, but levels under the diagnostic standards of diabetes type
2. Prediabetes is an intermediate phase of hyperglycemia, even though there is no general
agreement about the beginning of its determination. The American diabetes Association (ADA)
said that it is characterized by glucose on disturbed fast (100-125 mg/dl), tolerance to
disturbed glucose (140-199 mg/dl) and/or glycosylated hemoglobin, (HbA1c) which is around
5,7% and 6,4%. The World Health Organization (WHO) indicates that the beginning of
prediabetes in glucose in fast is 110-125 mg/dl2. The etiology of prediabetes is mainly the
resistance to insulin of skeletal muscle, the liver and / or adipose tissue which, and by the
time, promotes excessive insulin secretion of B cells and produces a pancreatic exhaustion
that produces severe hyperglycemia. The resistance to insulin of skeletal muscle is the
essential responsible for the intolerance to glucose (IGT, postprandial glucose at 2 h> 140
mg/dl). On the other hand, the resistance to hepatic insulin is shown mainly as an alteration
of glucose in fast (IFG; plasma glucose in fast >100 mg/dl), this last, because the
production of glucose is excessive despite normal insulinemia. There are several research
which prove that diabetes has a relation cause-effect with cardiovascular illness and
mortality in all vascular causes. However, it is not an unavoidable process but reversible.
Even though it is probable that prediabetes will be the result of multiple factors, the
deteriorated mitochondrial function is the main factor that contributes to the etiology of
resistance to insulin, a crucial sign of this illness. The intervention designed to increase
oxidative capacity in adults with diabetes, therefore, could relieve resistance to insulin
and improve tolerance to glucose. Physical exercise is a vital known strategy to prevent,
care and control diabetes type 2 and prediabetes.
Energy deficit after high intensity exercise contributes to increasing the sensibility of
insulin. In fact, an Energy deficit of about 6,5 kcal/kg of corporal weight after a series of
severe exercise resulted in an increase of the area under the curve (AUC) of postprandial
insulin about 22% lower during an oral glucose tolerance test (OGTT). This last, in
comparison with a reduction of 11% when there is a replacement of expended calories. This
suggests that approximately 50% of the effect of the exercise to insulin sensibility is the
result of energy deficit because of the exercise.
The high-intensity interval training (HIIT) can increase the oxidative capacity in comparison
to continuous training in healthy individuals, which suggests the variation in fat oxidation
depends on the intensity. This last observation is clinically relevant since fat oxidation
during exercise is directly related to insulin sensitivity. The changes included for the HIIT
in the mitochondrial function can explain its greater efficiency to provoke positive
metabolic adaptations in comparison with traditional training treatment protocols of
resistance, even when there is no diet intervention test to lose weight. Interval training
(HIIT), training with corporal weight, and functional training has emerged as some attractive
options to program therapeutic exercise in the ambit of physiotherapy. This is used as a
systematic way and safe in different populations, including people at chronic illness risk.
Excess weight (body mass index (BMI) ≥ 25.0 kg/m2) and obesity (BMI ≥ 30.0 kg/m2) are common
contributors to pain and disability in the musculoskeletal system, especially in the female
population. Excessive weight increases mechanical stress on the joints and tissues of the
body and cause physical limitations and body pain. It is evident an increase of pain severity
in higher body mass index (BMI) ratings. With 40% of women worldwide classified as overweight
and 15% as obese, the relation between pain and BMI may evolve as a growing challenge for the
health system. The evidence suggests that obesity modulates pain through several mechanisms,
such as mechanical load, inflammation, and psychological state. Obesity has been associated
with markers of chronic inflammation, such as C-reactive protein levels, tumor necrosis
factor α, amyloid A and interleukin 6 and white blood cell counts. Therefore, the impact of
obesity on various musculoskeletal conditions may be due not only to the biomechanical stress
of obesity, but also to the systemic effects. The latter suggests that increased inflammation
caused by obesity may play a role in pain. The increased fat index and decreased muscle mass
have been significantly associated with musculoskeletal pain among women, having higher rates
of physical inactivity. Pain in obesity contributes to the deterioration of physical
capacity, health-related quality of life and functional dependence.
The research has shown that pain limits participation in physical activity in general.
Overweight and obese women have reported that fear of pain or injury during exercise is a
major barrier to a more active lifestyle, as well as an important impediment to exercise
adherence. However, physical activity, and especially resistance training, can prevent or
reverse pain symptoms by increasing muscle mass, muscle strength, and physical function,
helping stabilize joints, improve mobility, and improve proprioception. While acute exercise
can transiently exacerbate pain symptoms, regular participation in exercise can reduce the
severity or prevalence of pain. Also, while published attrition rates with regular exercise
are high (around 50%), exercise adherence can be improved with exercise modifications,
including accumulating several sets of exercise rather than one long session, which reduces
the joint's range of motion and replaces impact with non-impact activity. Regular exercise
has been identified as the primary prevention against more than 35 chronic conditions,
including obesity, conditions related to joint pain, anxiety, and depression. Exercise
stimulation can have a positive impact on chronic pain mediators by exerting
anti-inflammatory effects, increasing muscle strength and coordination, and improving
psychological outlook. A study conducted to evaluate the impact of a musculoskeletal pain
intervention before participating in a weight management program; the Physiotherapy
intervention aimed at decreasing musculoskeletal pain in obese individuals reported that
musculoskeletal pain was reduced for those who completed the program. Given these findings,
it is plausible that activity deterrence is a problem in this population. In contrast,
specialized musculoskeletal interventions have been shown to reduce pain and improve exercise
compliance even in chronic conditions.
The improvements in physical ability could take place if the exercise program includes
resistance training, to avoid poor outcomes with women's health. strength is closely related
to changes in the neuromusculoskeletal system, as well as reduction in muscle mass. The
inclusion of resistance exercise training in such programs can further increase performance,
skeletal muscle mass, resting metabolic rate, and energy expenditure and thus improve body
composition and overall health. Resistance exercise protocols that incorporate whole-body
movements, which aim to activate the entire neuromuscular system, can also improve the
functional ability to perform activities of daily living in people who demonstrate
neuromuscular limitations and reduced mobility.
Further to these conditions, emerging evidence indicates that movement patterns that increase
the risk of musculoskeletal alterations occur due to neuromuscular control deficits, which
lead to compensatory motor strategies. This lack of motor control or deficit in neuromuscular
function has been operationally defined as the neurological mechanisms underlying the
unconscious activation of dynamic constraints that occur in preparation for and in response
to joint movement. Clinically, these deficits in neuromuscular control manifest as deficits
in postural control and altered peripheral muscle activation, which arises from changes in
the central nervous system that adversely affect the control of the skeletal muscular system.
A core abdominal muscle training program improves the biomechanics of the lower extremities
and trunk. biomechanical patterns may be favorable for preventing exercise-related injuries.
Improving self-regulation skills is a critical component to physical activity interventions
that aim to reduce the risk of diabetes and promote independent long-term adherence. This
last is a scientific position statement by the American Heart Association and the American
Diabetes Association. Within this framework, the efficacy of self-regulation is a belief that
refers to the confidence to promulgate and carry out self-managing behaviors. It is critical
for successful long-term participation in behaviors such as physical activity. The
self-efficacy has been identified as a significant predictor of the adoption and maintenance
of physical activity behavior, as a mediator of the effects of the intervention on physical
activity and it has been identified as the most influential factor of behavior change within
the literature on physical activity. In this way, fostering strong beliefs about social,
physical, and self-assessment outcomes, through therapeutic education, have the potential to
influence people's motivation to adhere to an exercise program in Physiotherapy.
Advocating for a lower volume of physical activity is of potential importance for exercise
adherence, as "lack of time" is the most common cited perceived barrier to regular
participation in exercise. Lack of local facilities for physical exercise, as well as the
economic resources that are invested in this aspect, especially in developing countries are
important obstacles for people to continue in training programs. Therefore, the recent
alternative of HIIT protocols performed with body weight is gaining more and more strength.
