ObesityNCT06442371
Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training in Obese Adults
A study testing High Intensity interval training + Quranic Listening and High intensity interval training in people with Obesity, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High Intensity interval training + Quranic Listening and High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
physiotherapy department, Jinnah international hospital
Abbottābād, Khyber PkahtoonKhwa
About this study
Official title: Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training on Cardiovascular Fitness and Mental Health in Obese Adults
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.
- Conditions
- Obesity
- Being tested
- High Intensity interval training + Quranic Listening, High intensity interval training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity interval training + Quranic ListeningOther
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 trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| High Intensity interval training + Quranic Listening | Experimental | Not described Receives: Other: High Intensity interval training + Quranic Listening |
| High Intensity interval training | Active comparator | Not described Receives: Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 May 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442371
- Sponsor's protocol ID
- Rec/01809 Warda Zaman
- Status last verified
- Jul 2024
- First submitted
- 29 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training on Cardiovascular Fitness and Mental Health in Obese Adults
- ClinicalTrials.gov ID
- NCT06442371
- Acronym / sponsor ID
- Rec/01809 Warda Zaman
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity interval training + Quranic ListeningIn 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. | Other | High Intensity interval training + Quranic Listening |
| High intensity interval trainingIn 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 | Other | High Intensity interval training |
Primary outcome
Modified BORG Scale
Time frame: 6 week
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 Min walk test (Distance in meters)
Time frame: 6 week
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).
Peak VO2 with formula
Time frame: 6 week
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
Body Mas Index
Time frame: 6 week
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).
Heart Rate recovery
Time frame: 6 week
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.
Depression Anxiety and Stress Scale
Time frame: 6 week
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.
Systolic and diastolic blood pressure
Time frame: 6 week
Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer
Change in blood lipid profile
Time frame: 6 week
Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity interval training + Quranic Listening and High intensity interval training in people with Obesity, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified BORG Scale (time frame: 6 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.