Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women

NCT03137849 | Completed DMC

• 1 other identifier: 5273/16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Autonomic and endothelial imbalance in post menopause women raise the need to manage cardiovascular risk. Yoga poses and breathing control present controversial results on prevention and treatment of hypertension.. The aim of this study is to compare the effect of 12 week intervention based on yoga poses and their muscle contractions known as bandhas (pelvic floor, core and throat/neck) and ujjayi pranayama (victorious breath) on autonomic modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function of hypertensive post-menopausal women.

Conditions

Hypertension; Postmenopausal Symptoms

Keywords

Yoga; Hypertension; Post-Menopausal Women; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Cardiovascular autonomic control by heart rate variability(HRV) and blood pressure variability (BPV) in frequency domain acquired by Finometer

  Sympathovagal balance HRV (ratio of low frequency (LF in ms2) and high frequency (HF in ms2) components of HRV = LF/HF)

  30 minutes

Secondary Outcomes (14)

• Carotid -femoral pulse wave velocity (Complior)

  10 minutes

• Maximal Oxygen Uptake by Cardiopulmonary Exercise Test

  45 minutes

• Ambulatory Arterial Pressure Monitoring

  24 hours

• Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt

  30 minutes along with Finometer

• Blood samples laboratorial analysis

  5 minutes

Study Arms (4)

Yoga Poses + Breath control

ACTIVE COMPARATOR

Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas with specific muscles contractions) combined with ujjayi pranayama technique as breath control

Other: Yoga Poses; Other: Breath Control

Yoga Poses

ACTIVE COMPARATOR

Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions)

Other: Yoga Poses

Stretching Exercises + Breath control

ACTIVE COMPARATOR

Twice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control

Other: Breath Control; Other: Stretching exercises

Stretching Exercises

ACTIVE COMPARATOR

Twice a week 75 minutes video class of stretching exercises routine

Other: Stretching exercises

Interventions

Yoga Poses OTHER

Yoga poses routine including specific muscles contractions known as bandhas (pelvic floor, core and throat/neck contraction) within each pose, which are advised to be done with steadiness and comfort.

Yoga Poses; Yoga Poses + Breath control

Breath Control OTHER

Ujjayi pranayama (Victorious breath) Inhalation and exhalation are both done through the nose. The "ocean sound" is created by moving the glottis as air passes in and out. As the throat passage is narrowed so, too, is the airway, the passage of air through which creates a "rushing" sound. The length and speed of the breath is controlled by the diaphragm, the Strengthening of which is, in part, the purpose of ujjayi. The inhalations and exhalations are equal in duration.

Stretching Exercises + Breath control; Yoga Poses + Breath control

Stretching exercises OTHER

Stretching exercises routine based on dynamic and static exercises excluding those similar to yoga poses. This routine works on great range of motion of all body joints and main muscles groups/ chains.

Stretching Exercises; Stretching Exercises + Breath control

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FSH\>35mui/ml
• minimum 12 months amenorrhea
• sedentary life style (less than 150 minutes per week of exercise)
• never been in yoga -practicing (self declaration)
• Blood pressure \> 140/90 or in continuous use of medication (diuretics,Ca+ channel inhibitors, ACE inhibitors)

You may not qualify if:

• Use of Betablockers
• recent cardiovascular events or surgery
• renal alterations
• respiratory and/or motor pathologies
• smoking
• BMI\>34,9

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Cardiology Institute of Rio Grande do Sul

Pôrto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Cláudia Irigoyen, PhD

  Institute of Cardiology/ University Foundation of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will be told they are attending to a yoga protocol. All outcomes assessments will be taken by blind investigators to the interventions.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: May 3, 2017
• Study Start: July 18, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 20, 2018
• Last Updated: July 23, 2019

Record last verified: 2017-07

Locations

BR (1)