NCT06656130

Brief Summary

Objective of our study is to determine the comparative effects of Pranayama and Jacobson's Relaxation Technique on cardiovascular parameters, stress and quality of life in Pre-hypertensive patients. This study is used to determine the effects of Pranayama versus Jacobson's Progressive Muscle Relaxation Technique on cardiorespiratory parameters, stress and quality of life in pre-hypertensive patients. This randomized clinical trial (RCT) endeavors to enroll \_\_\_ participants, divided equally into Pranayama and Jacobson's Progressive Muscle Relaxation Technique groups. The non-probability convenient sampling technique, followed by random allocation using a lottery method, ensures a diverse yet unbiased sample. Study is being conducted at the Kashmir Medical Complex Sialkot. The Pranayama group(n=25) undergoes sessions three times a week, emphasizing breathing techniques like alternate nostril technique and bellow breathing. The Jacobson's Progressive Muscle Relaxation Technique group(n=25) follows a similar schedule, engaging in full-body relaxation exercises targeting major muscle groups. Parameters will be assessed on 1st day, 3rd week and 8th week by outcome measures, SPSS version 23 will be used for analysis.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 23, 2024

Last Update Submit

October 23, 2024

Conditions

Keywords

: Jacobson's Progressive Muscle Relaxation Technique, Pranayama, Pre-hypertension

Outcome Measures

Primary Outcomes (2)

  • PSR (Perceived Stress Scale)

    The Perceived Stress Scale (PSS) is one of the most widely used instruments to measure stress perceptions. The original PSS is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful". It is a global measure of stress, rather than a measure of specific stressful life events. Specifically, items assess the extent to which one's life is perceived as "unpredictable, uncontrollable, and overloading

    8 weeks

  • SF-12 (QOL)

    Quality of life (QOL) is a broad multidimensional concept that usually includes subjective evaluations of both positive and negative aspects of life. The SF-12 Health Survey version 2 (SF-12v2) is a generic short-form health survey developed in the USA from the original SF36. It produces two summary measures evaluating physical and mental self-perceived health; for this reason, it could be a suitable and complete tool to assess the self-perceived quality of life of university students because it allows investigating both the aspects

    8 weeks

Study Arms (2)

Effects of Pranayama on cardiovascular parameters, stress and quality of life in pre-hypertension

EXPERIMENTAL

This group will receive Pranayama. Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. You purposely inhale, exhale, and hold your breath in a specific sequence. Interventions will be performed for 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24). Breathing exercises will be consist on Alternate Nostril Technique, Skull Shinning Technique, Bellow Breath, Bee Breath, Victorious Breath

Other: Pranayama

effects of Jacobson's technique on CVS parameters, stress and QOL in Pre-hypertension

EXPERIMENTAL

This group will receive Jacobson's Progressive Muscle Relaxation Technique. Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, you can become more aware of your body and physical sensations, The sessions will consist of 30 minutes in a day, 3 days per week for 8 weeks. (total no. of sessions=24).

Other: Jacobson's progressive muscle relaxation technique

Interventions

Pranayama is the practice of breath regulation. It's a main component of yoga, an exercise for physical and mental wellness. The practice of pranayama involves breathing exercises and patterns. Patient purposely inhale, exhale, and hold his/her breath in a specific sequence.

Also known as: Breathing Technique
Effects of Pranayama on cardiovascular parameters, stress and quality of life in pre-hypertension

Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific 14 muscle groups in sequence. It's also known as progressive relaxation therapy. By concentrating on specific areas and tensing and then relaxing them, patient can become more aware of his/her body and physical sensations,

Also known as: Breathing and stretching technique
effects of Jacobson's technique on CVS parameters, stress and QOL in Pre-hypertension

Eligibility Criteria

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

You may qualify if:

  • Age: Participants must be between 30 and 60 years old.
  • Gender: Male and Female both.
  • Diagnosed patients of Pre-hypertension.
  • Stable health condition to participate in moderate physical activities.
  • Willing to comply with the study protocol, including attending scheduled exercise sessions and follow-up assessments

You may not qualify if:

  • Diagnosed case of Hypertension or takes any antihypertensive medication.
  • Patient having any other associated systemic disorder are excluded.
  • Severe physical limitations, disabilities, or musculoskeletal disorders.
  • History of substance abuse.
  • Patients with Neurological diseases
  • Patients with severe or unstable heart conditions, recent heart attack, or heart failure, other cardiovascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sialkot Medical and Physiotherapy Center

Sialkot, Punjab Province, 51310, Pakistan

Location

MeSH Terms

Conditions

Prehypertension

Interventions

Respiration

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Sumera AbdulHameed Supervisor/ Research Incharge, M.PHIL

    Riphah International University Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

April 15, 2024

Primary Completion

December 15, 2024

Study Completion

January 1, 2025

Last Updated

October 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations