Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older Hypertensive

Official title

Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older

Overview

BACKGROUND: Physical exercise promotion is one of the main global goals of innumerous health and medical societies for preventing and managing noncommunicable chronic diseases (NCDs), being one of the main therapeutic for the patient with hypertension. Exercise in heated swimming pool has emerged as a potential alternative to physical exercise on the ground for the reduction of blood pressure (BP) of hypertensive patients, however, its effects on BP, as well as hemodynamic, metabolic, inflammatory and functional variables of older individuals with hypertension have not been investigated. PURPOSE: To evaluate the effects of heated water-based exercise (HEx) versus land-based exercise (LEx) on BP, arterial stiffness, endothelial function, metabolic, inflammatory and functional variables of older individuals with hypertension. METHODS: 60 older individuals (male and female) with hypertension (age \> 60 years) will be randomized in 2:2:1 ratio to HEx, LEx or control (CON) intervention. The feasibility and physiological adaptations (physical capacity, musculoskeletal and cardiovascular responses to stress, biological and biochemical markers associated with the pathophysiology of the disease and vascular adaptations) will be assessed before, after 12 weeks and after 24 weeks of follow-up. HEx and LEx training programs will be performed three times per week and will be performed for the firs 12 weeks of follow-up.

Interventions

• Other Physical Exercise Session in heated Swimming Pool - HEx
  Warm Up - 5 minutes of stretching and heating of the joints and muscle groups to be worked; Aerobic exercise - 30 minutes of aerobic exercise (following the same control parameter of the experimental session); Resistance exercises - 20 minutes of resisted exercises, which will be divided into 6 exercises with 2 sets of 10 to 15 repetitions (following the same control parameter of the experimental session); Calm back - 5 minutes of stretching.
• Other Physical Exercise Session in Land- LEx
  Warm up - 5 minutes of stretching and heating of the joints and muscle groups to be worked; Aerobic exercise - 30 minutes of aerobic exercise performed on treadmill and / or exercise bike (following the same control parameter of the experimental session); Endurance Exercises - 20 minutes of exercises resisted, also divided into 6 exercises with 2 sets of 10 to 15 repetitions. The large muscle groups of the upper limbs, lower limbs and trunk will be exercised in fitness machine and with free weig
• Other Control Session Without Exercise- CON
  Guidance to maintain the usual level of physical activity and not to enter physical exercise programs during the 12 weeks of follow-up.

Primary outcome measures

• Blood pressure change [Time frame: baseline, 3 month and 6 month]

Secondary outcome measures (11)

• Arterial stiffness [Time frame: baseline, 3 month and 6 month]
• Brachial artery flow-mediated dilation (FMD) [Time frame: baseline, 3 month and 6 month]
• Maximal oxygen consumption [Time frame: baseline, 3 month and 6 month]
• First ventilatory threshold (anaerobic threshold) [Time frame: baseline, 3 month and 6 month]
• Change from baseline in the second ventilatory threshold (respiratory compensation point) [Time frame: baseline, 3 month and 6 month]
• Exercise tolerance [Time frame: baseline, 3 month and 6 month]
• Handgrip strength [Time frame: baseline, 3 month and 6 month]
• Flexibility [Time frame: baseline, 3 month and 6 month]
• Lower-limb strength [Time frame: baseline, 3 month and 6 month]
• Agility and balance [Time frame: baseline, 3 month and 6 month]
• Endurance performance [Time frame: baseline, 3 month and 6 month]

Eligibility criteria

Inclusion criteria

\- For the study population, the following will not be included in the study:

• Smokers (avoiding acute effects of smoking on physiological measures);
• Individuals with decompensated cardiovascular disease, thyroid dysfunction and / or inflammatory diseases;
• Unable individuals to perform an exercise program or ergospirometric test due to physical or mental incapacity;
• Individuals with hemodynamic and / or electrocardiographic changes during the ergospirometric test.
• Only individuals older than 60 years, with a diagnosis of SAH for more than 6 months (stage 1 or 2), using antihypertensive medication (office BP less than 140/90 mmHg) and without medication change for at least 2 months.

Exclusion criteria

• For the study population, individuals who have less than 60% adherence to scheduled physical exercise sessions will be excluded during the study.
• Individuals who change or discontinue their clinical and / or pharmacological treatment (with or without a prescription).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Brazil · 1 center

• Universidade Estadual Paulista Julio de Mesquita Filho — Bauru

Identifiers

NCT: NCT07131748 · 2017/25648-4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗