NCT05684666

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

January 5, 2023

Last Update Submit

August 23, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Systolic Blood Pressure (SBP)

    SBP was measured using a portable electronic sphygmomanometer.

    8 Weeks

  • Diastolic Blood Pressure (DBP)

    DBP was measured using a portable electronic sphygmomanometer.

    8 Weeks

  • Heart Rate (HR)

    Heart Rate was measured using a portable electronic sphygmomanometer.

    8 Weeks

  • Respiratory Rate (RR)

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

    8 Weeks

  • Perceived Stress (PS)

    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").

    8 Weeks

Study Arms (4)

SBE Group

EXPERIMENTAL

Slow Breathing Exercise (SBE) was performed by the participants of SBE group. Sixteen participants included in this group.

Other: Slow Breathing Exercise (SBE)

PMR Group

EXPERIMENTAL

Progressive Muscle Relaxation (PMR) Technique was performed by the participants of the PMR group. It included 16-participants for the study.

Other: Progressive Muscle Relaxation (PMR) Technique

Combined Group

EXPERIMENTAL

Sixty participants from the combined group performed both Slow Breathing Exercise and Progressive Muscle Relaxation technique in this study.

Other: Slow Breathing Exercise (SBE)Other: Progressive Muscle Relaxation (PMR) Technique

Control Group

NO INTERVENTION

No intervention was received/performed by the sixteen participants of the control group in this study.

Interventions

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.

Combined GroupSBE Group

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.

Combined GroupPMR Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Riyadh, Riyadh 11433, 10219, Saudi Arabia

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Autogenic TrainingMethods

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesInvestigative Techniques

Study Officials

  • AMIR IQBAL, MPT

    King Saud University, Riyadh 11433, P.BOX 10219, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

February 21, 2019

Primary Completion

September 30, 2019

Study Completion

October 26, 2019

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations