Effect of Aerobic Training on the Health Parameters of Postmenopausal Women With Multimorbidity

NCT05075902 | Suspended DMC

• 1 other identifier: CAAE: 12453719.1.0000.5152
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

People affected by multiple chronic diseases have a greater chance of hospitalization, longer hospital stays, worse general health, worse physical and mental function and lower functional capacity, with an average risk of 50% of functional decline with each additional condition. The frequency of multimorbidity is higher in older, inactive women, who live in urban areas in low- and middle-income countries, the most affected by multimorbidity. The practice of physical exercise is an important component in the prevention of multiple chronic diseases, in which lower levels of physical activity were associated with an increased prevalence of multimorbidity in women aged 16 to 24 years. And regardless of the presence of multimorbidity, engaging in a healthier lifestyle, including regular physical activity, was associated with up to 7.6 more years of life for women, improving the individual's general health status even when multimorbid. The hypothesis is that multimorbid women have a worse general health status when compared to women without multimorbidity, but aerobic exercise will be able to improve health parameters in 12 weeks of training. This is a quasi-experimental clinical trial with a 12-week aerobic training intervention in postmenopausal women with and without cardiometabolic multimorbidity. Participants were allocated into groups according to the amount of cardiometabolic diseases, with the Morbidity group (MORB) being composed of women with one or no chronic cardiometabolic disease and the Multimorbidity group (MULTI) with two or more chronic cardiometabolic diseases. The assessments of arterial stiffness, 24-hour ambulatory pressure, blood pressure variability, heart rate variability, lipid and glucose profile, body composition and climacteric symptoms were performed before and after the training period. The study was carried out at the Laboratory of Cardiorespiratory and Metabolic Physiology at the Faculty of Physical Education of the Federal University of Uberlândia, Uberlândia, Brazil and approved by the Ethics Committee for studies in humans (CAEE: 12453719.1.0000.5152). All participants signed a consent form. The experiments followed the principles of the Declaration of Helsinki. The program consists of aerobic physical exercises performed three times a week on non-consecutive days for 12 weeks with an intensity of 65% to 75% of the reserve heart rate.

Conditions

Multimorbidity; Multiple Chronic Conditions; Hypertension; Dyslipidemias

Keywords

aerobic training; multimorbidity; menopause; blood pressure; arterial stiffness

Outcome Measures

Primary Outcomes (5)

• Change in Arterial stiffness in 12 weeks

  Arterial stiffness was assessed by measuring the Pulse Wave Velocity (PWV) through the applanation tonometry method, performed on 3 measurements and the average of the three was performed to obtain the final value. It is a non-invasive, painless method with instantaneous results and considered the gold standard for determining arterial stiffness. This method is based on the principles of ocular tonometry used to measure intraocular pressure by "flattening" the surface of the eyeball.

  Before and after 12 weeks of intervention

• Change in Lipid profile in 12 weeks

  The blood samples were collected after an overnight fast, five days before, and 72 h after, the last exercise training session to eliminate the acute effects of the exercise. Plasma concentrations of total cholesterol (mg/dL), triglycerides (mg/dL), high density lipoprotein (HDL) (mg/dL) and low density lipoprotein (LDL) cholesterol (mg/dL) were determined by enzymatic colorimetric methods. All analyzes were performed using an automated system using commercial kits.

  Before and after 12 weeks of intervention.

• Change in 24-hour ambulatory blood pressure in 12 weeks

  Blood pressure (Systolic, diastolic, mean) (mmHg) was assessed before and after 12 weeks of training through ambulatory monitoring (ABPM) using the Dyna Mapa+ device (São Paulo, Brazil). The monitor was programmed with measurements every 30 minutes for 24 hours, standardizing the start of monitoring in the morning between 7 am and 8 am. Along with the monitor, the participants filled out a daily record of activities (sleep, food and work) or events that could interfere with blood pressure or measurements, with sleep and wakefulness periods being individually determined according to the time reported in each diary. Measurements obtained 24 hours of monitoring and with at least 70% of measurements valid in this period were considered valid.

  Before and after 12 weeks of intervention.

• Change in glycated hemoglobin (HbA1c)

  The blood samples were collected after an overnight fast, five days before, and 72 h after, the last exercise training session to eliminate the acute effects of the exercise. The concentration (%) of glycated hemoglobin (HbA1c) was determined by the turbidimetry method. All analyzes were performed using an automated system, using commercial kits.

  Before and after 12 weeks of intervention.

• Change in glucose

  The blood samples were collected after an overnight fast, five days before, and 72 h after, the last exercise training session to eliminate the acute effects of the exercise. Plasma concentrations of glucose (mg/dL) were determined by enzymatic colorimetric methods. The analyze was performed using an automated system using commercial kit.

  Before and after 12 weeks of intervention.

Secondary Outcomes (6)

• Blood Pressure Variability

  Before and after 12 weeks of intervention

• Heart rate variability

  Before and after 12 weeks of intervention

• Assessment of anthropometry

  Before and after 12 weeks of intervention

• Assessment of climacteric symptoms - Cervantes Quality of Life Scale

  Before and after 12 weeks of intervention.

• Change in Body composition in 12 weeks

  Before and after 12 weeks of intervention.

Study Arms (2)

Multimorbidity Group (MULTI)

EXPERIMENTAL

Multimorbidity group is composed of post menopausal women with two or more chronic diseases cardiometabolic (Hypertension, diabetes, dislipidemias, obesity).

Behavioral: Aerobic training

Morbidity Group (MORB)

EXPERIMENTAL

Morbidity group is composed of postmenopausal women with one or no chronic cardiometabolic disease (Hypertension, diabetes, dislipidemias, obesity)

Behavioral: Aerobic training

Interventions

Aerobic training BEHAVIORAL

The program consists of aerobic exercise performed three times a week on non-consecutive days for 12 weeks at an intensity of 65% to 75% of the reserve heart rate. During the first 4 weeks of training, the exercise duration was 40 minutes (5' warm up + 30 minutes in the intensity zone + 5' cool down). From the fifth week onwards, there was only an increase in volume to 50 minutes in duration (5'warm-up + 40 minutes in the intensity zone + 5'warm-up). The aerobic fitness assessment was performed on a maximal effort ergospirometric treadmill under the supervision of a qualified physician, using the Bruce protocol (adapted) to assess cardiopulmonary capacity (to assess possible cardiovascular capacity that prevents the proposed training) and for individualized training prescription.

Also known as: Aerobic physical exercise

Morbidity Group (MORB); Multimorbidity Group (MULTI)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (amenorrhea of at least 12 months; Estradiol \<32.2 pg / mL),
• Aged between 50 and 70 years,
• Able to do aerobic exercise on track, do not have physical problems or cardiovascular complications that prevent them from exercising.
• Non-smokers ,
• Who do not use Hormone Therapy or have not finished the treatment for more than 1 year,
• As diagnostic criteria for cardiometabolic diseases: Obesity (BMI\> 29.9 kg / m2; Use of antihypertensive drugs and/or hypertension (systolic blood pressure at rest \> 139 mmHg and diastolic blood pressure \> 89 mmHg; dyslipidemia (LDL ≥160mg / dL and / or triglycerides ≥150mg / dL and / or total cholesterol ≥190mg / dL and / or HDL ≤50mg / dL. In the case of diabetics (blood glucose \> 126 mg / dL and / or HbA1c ≥ 6.5% and diagnosed with type 2 diabetes mellitus: for at least one year, being using a hypoglycemic and clinically stable for up to minimum 6 months, with glycemic control by medication or exogenous insulin and without chronic complications such as diabetic foot, nephropathy, retinopathy or neuropathies.

You may not qualify if:

• Present some inability to carry out the prescribed training volume or intensity,
• Not obtain medical clearance after maximum exercise test
• Start practicing another physical exercise protocol concurrently with this project.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

Related Publications (8)

• Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.

  PMID: 17000623 BACKGROUND

• Kario K, Matsuo T, Kobayashi H, Imiya M, Matsuo M, Shimada K. Nocturnal fall of blood pressure and silent cerebrovascular damage in elderly hypertensive patients. Advanced silent cerebrovascular damage in extreme dippers. Hypertension. 1996 Jan;27(1):130-5. doi: 10.1161/01.hyp.27.1.130.

  PMID: 8591875 BACKGROUND

• Lima JE, Palacios S, Wender MC. Quality of life in menopausal women: a Brazilian Portuguese version of the Cervantes Scale. ScientificWorldJournal. 2012;2012:620519. doi: 10.1100/2012/620519. Epub 2012 Mar 12.

  PMID: 22500142 BACKGROUND

• Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28.

  PMID: 12914663 BACKGROUND

• Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.

  PMID: 15345062 BACKGROUND

• Banegas JR, Ruilope LM, de la Sierra A, Vinyoles E, Gorostidi M, de la Cruz JJ, Ruiz-Hurtado G, Segura J, Rodriguez-Artalejo F, Williams B. Relationship between Clinic and Ambulatory Blood-Pressure Measurements and Mortality. N Engl J Med. 2018 Apr 19;378(16):1509-1520. doi: 10.1056/NEJMoa1712231.

  PMID: 29669232 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.

  PMID: 24054542 BACKGROUND

MeSH Terms

Conditions

Multiple Chronic Conditions; Hypertension; Dyslipidemias

Interventions

Exercise

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juliene Dechichi, MSc

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

• Guilherme Puga, PhD

  Federal University of Uberlandia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The Care Providers followed the standard of care for all participants during the training sessions, with a standardized approach such as: measuring the blood pressure of all participants before starting the training session, intensity control during training was done by zone of individualized heart rate, regardless of the group, presented in a spreadsheet without information about the group to which the patient was assigned. The outcomes assessor were not aware of the formation of groups and access only to the participants' codes, were objective and with generation of saved files for later conference by the Investigator.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Juliene Gonçalves Costa Dechichi

Model Details: This is a quasi-experimental controlled trial with a 12-week aerobic training intervention in postmenopausal women with and without cardiometabolic multimorbidity. Participants were allocated into groups according to the amount of cardiometabolic diseases, with the Morbidity group (MORB) being composed of women with one or no chronic cardiometabolic disease and the Multimorbidity group with two or more chronic cardiometabolic diseases.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: October 13, 2021
• Study Start: February 1, 2019
• Primary Completion: March 18, 2020
• Study Completion: March 1, 2022
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)