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Completed

NCT Number: NCT05684666

Effect of Breathing and Muscle Relaxation Technique in Individual With Essential Hypertension

Primary hypertension, also called essential hypertension, is a rise in blood pressure (BP) with no identifiable cause. The most prevalent form of hypertension is essential hypertension, which involves 95% of patients with hypertension.Progressive muscle relaxation (PMR) is learning to relax some groups of muscles while paying attention to the feelings connected with both the tense and relaxed states.It is generally established that regular slow (deep) breathing exercises enhance respiratory and cardiovascular function by enhancing parasympathetic tone and reducing sympathetic activity, thus reducing BP, heart rate, respiratory rate, and stress levels in hypertensive patients. This study aimed to investigate the combined effect of slow breathing and PMR technique on BP, heart rate, respiratory rate, and anxiety in patients diagnosed with essential hypertension.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

Riyadh, Riyadh 11433, 10219, Saudi Arabia

About this study

From the previously published literature, it is obvious that both slow breathing and PMR and slow breathing is effective in patients with essential hypertension. However, no studies are available on the combined effect of these two techniques. So, the study aims to investigate the combined effect of slow breathing and PMR technique on BP, heart rate, respiratory rate, and anxiety in patients diagnosed with essential hypertension.

Sixty-four participants diagnosed with essential hypertension were randomly allocated into four groups (Slow breathing (SB), PMR, SB+PMR, Control) with 16 subjects in each. Baseline BP, HR, RR and perceived stress scale were taken. All three-intervention groups underwent 30 minutes of training three days before the day of the intervention. The intervention consisted of 30 minutes, pre, mid and post-intervention BP, HR, RR and Perceived Stress (PS) were measured. The control group rested for 30 minutes. Pre, mid and post-rest measurements of BP, HR, RR and PS were taken.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with essential hypertension, a diastolic BP between 90 to 109mm of Hg, a systolic BP of more than 140mm of Hg,
  • Aged between 30 to 60 years, and
  • Self co-operation.

Exclusion criteria

  • Participants with secondary hypertension, any physical abnormalities that may disturb the exercise intervention,
  • Participant who cannot perform any relaxation or breathing exercises, and
  • Non-cooperation of participants.

Treatment and study plan

Slow Breathing Exercise (SBE)

Other

Slow Breathing Exercise (SBE) delivered in a relaxed supine posture on a couch with keeping the feel flat and knee flexed to 90 degree.

Participants were instructed to make six breaths per minute for 30 minutes per session, twice a week for 4 weeks.

Progressive Muscle Relaxation (PMR) Technique

Other

Progressive Muscle Relaxation (PMR) Technique delivered in a relaxed supine posture on a couch with keeping the feel flat and knee flexed to 90 degree.

Participants were instructed to complete all sixteen steps of PMR technique for 30 minutes per session, twice a week for 4 weeks.

Primary outcomes

  1. Systolic Blood Pressure (SBP)

    Time frame: 8 Weeks

    SBP was measured using a portable electronic sphygmomanometer.

  2. Diastolic Blood Pressure (DBP)

    Time frame: 8 Weeks

    DBP was measured using a portable electronic sphygmomanometer.

  3. Heart Rate (HR)

    Time frame: 8 Weeks

    Heart Rate was measured using a portable electronic sphygmomanometer.

  4. Respiratory Rate (RR)

    Time frame: 8 Weeks

    RR was measured manually as the number of breaths a participant takes per minute.

  5. Perceived Stress (PS)

    Time frame: 8 Weeks

    Perceived Stress was assessed using the perceived stress scale (PSS) with ten items, each with a five-point Likert scale (where a score of 0 indicates "never," a score of 1 indicates "nearly never," a score of 2 "occasionally," a score of 3 "very often," and a score of 4 "often").

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Effect of Slow Breathing and Progressive Muscle Relaxation Technique in Individual With Essential Hypertension: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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