SleepNCT06230094
Effect of 8 Weeks Moderate & High Intensity Training on Cognitive Functions and Sleep of Female Students
A study testing moderate intensity and high intensity in people with Sleep and Cognition, run by Riphah International University at 1 site in Pakistan.
Trial summary
this study aims to assess ther effectiveness of moderate \& high intensity training on cognitive functions and sleep of female students Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- What is being tested?
- moderate intensity and high intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to May 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female students
- age between 18- 25
Who cannot join
- History of trauma/ injury
- mental illness
- physical deformity
- infection,fever
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Sargodha institute of health sciences
Sargodha, Punjab Province, 40100
Waqar Ahmed, PHD, 0333-5348846, waqar.ahmed@riphah.edu.pk
Tabinda Kanwal, DPT, 03130565718, tabindakanwal25@gmail.com
About this study
this study aims to assess ther effectiveness of moderate \& high intensity training on cognitive functions and sleep of female students
Read the detailed description
In group A for moderate intensity training brisk walk will be performed(HR will be between 50%- 60% of maxHR).
warmup exercise will be performed to achieve 50%HR and then brisk walk will be performed till she reaches 60%HR.
This protocol will be followed for 5days per week. In group B for high intensity training skipping rope will performed (HR will be between 70%-85% of maxHR).
warmup exercise will be performed to achieve 70%HR and then skipping rope will be performed till she reaches 85%HR.
This protocol will be followed for alternative 3days per week.
- Being tested
- moderate intensity, high intensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate intensityOther
Arm Circles, Leg Swings, Lunges, brisk walk
high intensityOther
Arm circles, Leg swings, Lunges, skipping rope
| Study group | Role | What they receive |
|---|---|---|
| Group A ( moderate intensity training) | Experimental | warm up protocol to reach maxHR 50% than moderate intensity exercise. Group A will be given moderate intensity exercise i.e brisk walk will be performed.(HR will be between 50-60%). Receives: Other: moderate intensity |
| Group B( high intensity training) | Experimental | warm up protocol to achieve 70% of maxHR . group Bwill be given highintensity exercise i.e skipping rope ( HR will be between 70-85%). Receives: Other: high intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop test for Cognitive Function
The Stroop Color and Word Test, interference on reading ability through three sections: word page, color page, and word-color page, each containing 5 columns with 20 items. In a 45-second timeframe, participants rapidly read words or name ink colors. Overall, the Stroop test offers a comprehensive evaluation of cognitive abilities related to interference and reading skills.
Measured: 8 weeks
Pittsburg sleep quality index ,
Each of the seven component scores, encompassing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, is assigned a value on a scale ranging from 0 to 3. A score of 0 signifies an absence of difficulty, while a score of 3 reflects severe difficulty within the specific component. The calculation of the Global Pittsburgh Sleep Quality Index (PSQI) score involves summing up these seven component scores, resulting in a total score that ranges from 0 to 21. Elevated global scores are indicative of lower sleep quality, and a score exceeding 5 is generally construed as suggestive of poor sleep. In terms of interpretation, a global PSQI score falling between 0 and 5 is considered representative of "good" sleep quality, while a score surpassing 5 implies a lower quality of sleep.
Measured: 8 weeks
Digit span test
The Digit Span Test gauges short-term memory and attention span by having individuals repeat digit sequences in the same or reverse order. Scores are assigned per correctly repeated digit, with the test progressively increasing in difficulty. The total score reflects the longest accurately recalled sequences in both conditions. Interpretation reveals insights into working memory and attentional control, where a higher Digit Span Forward score signifies efficient short-term memory, while a higher Digit Span Backward score indicates superior working memory and cognitive flexibility in recalling and manipulating sequences in reverse order.
Measured: 8 weeks
Sleep quality scale
The Sleep Quality Scale (SQS) measures sleep quality in people who live in the general population.
Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) and are reversed before being tallied. Total scores can range from 0 to 84, with higher scores demoting more acute sleep problems.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Aug 2023
- Primary completion15 Mar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tabinda Kanwal, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230094
- Sponsor's protocol ID
- 014244 tabinda
- Status last verified
- Jan 2024
- First submitted
- 24 Nov 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 8 Weeks Moderate & High Intensity Training on Cognitive Functions and Sleep of Female Students
- ClinicalTrials.gov ID
- NCT06230094
- Acronym / sponsor ID
- 014244 tabinda
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 30 Jan 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.
this study aims to assess ther effectiveness of moderate \& high intensity training on cognitive functions and sleep of female students
Detailed description
In group A for moderate intensity training brisk walk will be performed(HR will be between 50%- 60% of maxHR).
warmup exercise will be performed to achieve 50%HR and then brisk walk will be performed till she reaches 60%HR.
This protocol will be followed for 5days per week. In group B for high intensity training skipping rope will performed (HR will be between 70%-85% of maxHR).
warmup exercise will be performed to achieve 70%HR and then skipping rope will be performed till she reaches 85%HR.
This protocol will be followed for alternative 3days per week.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ( moderate intensity training) | Experimental | Other: moderate intensitywarm up protocol to reach maxHR 50% than moderate intensity exercise. Group A will be given moderate intensity exercise i.e brisk walk will be performed.(HR will be between 50-60%). |
| Group B( high intensity training) | Experimental | Other: high intensitywarm up protocol to achieve 70% of maxHR . group Bwill be given highintensity exercise i.e skipping rope ( HR will be between 70-85%). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female students
- age between 18- 25
Key exclusion criteria (4 listed)
- History of trauma/ injury
- mental illness
- physical deformity
- infection,fever
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 |
|---|---|---|
| moderate intensityArm Circles, Leg Swings, Lunges, brisk walk | Other | Group A ( moderate intensity training) |
| high intensityArm circles, Leg swings, Lunges, skipping rope | Other | Group B( high intensity training) |
Primary outcome
Stroop test for Cognitive Function
Time frame: 8 weeks
The Stroop Color and Word Test, interference on reading ability through three sections: word page, color page, and word-color page, each containing 5 columns with 20 items. In a 45-second timeframe, participants rapidly read words or name ink colors. Overall, the Stroop test offers a comprehensive evaluation of cognitive abilities related to interference and reading skills.
Pittsburg sleep quality index ,
Time frame: 8 weeks
Each of the seven component scores, encompassing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, is assigned a value on a scale ranging from 0 to 3. A score of 0 signifies an absence of difficulty, while a score of 3 reflects severe difficulty within the specific component. The calculation of the Global Pittsburgh Sleep Quality Index (PSQI) score involves summing up these seven component scores, resulting in a total score that ranges from 0 to 21. Elevated global scores are indicative of lower sleep quality, and a score exceeding 5 is generally construed as suggestive of poor sleep. In terms of interpretation, a global PSQI score falling between 0 and 5 is considered representative of "good" sleep quality, while a score surpassing 5 implies a lower quality of sleep.
Digit span test
Time frame: 8 weeks
The Digit Span Test gauges short-term memory and attention span by having individuals repeat digit sequences in the same or reverse order. Scores are assigned per correctly repeated digit, with the test progressively increasing in difficulty. The total score reflects the longest accurately recalled sequences in both conditions. Interpretation reveals insights into working memory and attentional control, where a higher Digit Span Forward score signifies efficient short-term memory, while a higher Digit Span Backward score indicates superior working memory and cognitive flexibility in recalling and manipulating sequences in reverse order.
Sleep quality scale
Time frame: 8 weeks
The Sleep Quality Scale (SQS) measures sleep quality in people who live in the general population. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) and are reversed before being tallied. Total scores can range from 0 to 84, with higher scores demoting more acute sleep problems.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 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.
Tabinda Kanwal principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate intensity and high intensity in people with Sleep and Cognition, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waqae Awan, PHD (0333-534884, waqar.ahmed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop test for Cognitive Function (time frame: 8 weeks). The study lists 4 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 30 Jan 2024.