NCT06442371

Brief Summary

To determine the additional effects of Quranic listening meditation, in combination with High-Intensity Interval Training on cardiovascular fitness and mental health in obese adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable obesity

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

May 10, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 29, 2024

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Modified BORG Scale

    The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test. Changes from the baseline will be measured

    6 week

  • 6 Min walk test (Distance in meters)

    Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individual\'s height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).

    6 week

  • Peak VO2 with formula

    A generalized equation can be used to determined peak VO2 (Peak rate of oxygen consumption). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is: Mean peak VO2(ml/kg/mins) = 4.948 + 0.023\*Mean 6 MWD (meter) Changes From the Baseline will be measured

    6 week

  • Body Mas Index

    Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individuals height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).

    6 week

  • Heart Rate recovery

    Heart rate recovery (HRR) is a measurement of how quickly your heart can settle back into its normal state following a workout. It is the variation in heart rate between the time when you are exercising and when you stop.

    6 week

  • Depression Anxiety and Stress Scale

    Depression Anxiety and Stress Scale DASS (-42), The 42-item DASS-42 self-report scale was designed to measure the negative emotional states of stress, anxiety, and depression. As part of the larger process of clinical assessment, the DASS's main value in a clinical environment is to identify the location of emotional disturbance. The DASS's primary purpose is to evaluate the severity of the main symptoms of stress, anxiety, and depression.

    6 week

  • Systolic and diastolic blood pressure

    Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer

    6 week

  • Change in blood lipid profile

    Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.

    6 week

Study Arms (2)

High Intensity interval training + Quranic Listening

EXPERIMENTAL
Other: High Intensity interval training + Quranic Listening

High Intensity interval training

ACTIVE COMPARATOR
Other: High intensity interval training

Interventions

In this group, participants will receive protocol of High Intensity interval training which includes squats, jumping jacks, front kicks and rope jumps 3 days per week for 6 weeks, including warmup and cool down session along with Quranic listening meditation.

High Intensity interval training + Quranic Listening

In this group, participants will receive only High intensity interval training which includes squats, jumping jacks, front kicks and rope jumps 3 days per week for 6 weeks, including warmup and cool down periods with no Quranic listening meditation

High Intensity interval training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese adults (BMI ≥ 30)
  • Age range: 18-45 years
  • No previous experience with Quranic listening meditation since last 4 weeks.
  • No contraindications for engaging in high-intensity physical activity
  • Able to attend regular sessions at clinic and follow the study protocol.
  • Willingness to undergo pre and post-assessments for cardiovascular fitness and mental health measures.

You may not qualify if:

  • Individuals with a history of the medical condition being studied
  • Those who are currently taking medication that may affect the study
  • Participants with a history of mental health disorders
  • Individuals who are pregnant or breastfeeding
  • Those who have previously participated in a similar study
  • Participants with a history of substance abuse or addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

physiotherapy department, Jinnah international hospital

Abbottābād, Khyber PkahtoonKhwa, Pakistan

Location

MeSH Terms

Conditions

Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 4, 2024

Study Start

May 10, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations