StressNCT04925115
Effect of Physical Activity on Academic Stress While Controlling the Confounding Variables
A study testing Brisk walking in people with Stress, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study is designed to determine the effectiveness of moderate physical activity on academic stress with controlling and observing on confounding variables. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Brisk walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Dec 2020to 1 Sep 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Moderate academic stress
Who cannot join
- Participant falling in this category would be excluded from the study.
- Physical Disability
- Acute infection
- Chronic infection
- Acute inflammation
- Chronic inflammation
Show all 19Show fewer
- Known osteoporosis
- Individual with respiratory diseases e.g. asthma
- Smoking
- Musculoskeletal injuries
- Confounding variables:
- Age
- Gender
- BMI
- Socio-economic status
- Semester
- Depression, anxiety and stress
- Demographic (rural, urban)
- Relationship status (married and unmarried)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah international university
Islamabad, 44000
salman khan, MS-SPT, 03329365147, salman_khan201390@yahoo.com
Waqar Ahmed Awan, PhD
About this study
The study is designed to determine the effectiveness of moderate physical activity on academic stress with controlling and observing on confounding variables.
Read the detailed description
Now a days, modern time, new researches increased knowledge of researchers on physical activity and its effect on academic stress. Literature search shows to reduce academic stress among people all types of physical activities were effective and useful. Particularly moderate level of physical activity like brisk walking was significantly associated with academic stress, as compare to hard and light physical activities. Many Studies and research was available on the effectiveness of physical activities and found effective for dealing with academic stress but these were single centered and lacking control on confound variables observation, For example, Age, BMI, Socio-economic status, Semester pressure, Curriculum burden, depression, anxiety ,stress , demographics etc were absent in previous studies plus the available research is partial, includes only females. This research will be impartial and free from gender discrimination. Both male and female students will be taken in consideration for test and a multi-centered study will be conducted focusing on the confounding variables to determine the effectiveness of physical activity on academic stress with controlling variables is the recommendation of this research
- Conditions
- Stress
- Being tested
- Brisk walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk walkingOther
Also called Moderate physical activity
- Warm up and cool down (10 minutes before physical activity)
- Brisk walking ( 30 minutes each session for 5 days in a week)
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Interventional group:
1. Warm up and cool down (10 minutes before physical activity)
2. Brisk walking ( 30 minutes each session for 5 days in a week)
3. Week 1 to week 6 same protocol Receives: Other: Brisk walking |
| Control group | No intervention | Routine activity of daily life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic Stress scale
Academic Stress will be measured through 40 item scale (Academic Stress scale). It will be used during survey for inclusion criteria, This scale consists of 40 items describing the stress in your institution/ college life from the various sources.
Measured: 6 weeks
Perceived stress scale
Perceived stress scale will be measured through 10 questions in this scale ask you about your feelings and thoughts during the last month. In each case, you will be asked to indicate by circling how often you felt or thought a certain way. As 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often
Measured: 6 weeks
Depression, Anxiety and Stress Scale (DASS21)
Depression, anxiety and stress scale will be measured through 21 items scale. Moderate stress score is : 19-25
Measured: 6 weeks
Physical Activity Readiness Questionnaire (PAR-Q)
Physical Activity Readiness Questionnaire (PAR-Q)
Yes to one or more questions:
If you have not recently done so, consult with your doctor by telephone or in person before increasing your physical activity and/or taking a fitness appraisal. Tell your doctor what questions you answered 'yes' to on PAR-Q or present your
PAR-Q copy. After medical evaluation, seek advice from your doctor as to your suitability for:
Unrestricted physical activity starting off easily and progressing gradually, and Restricted or supervised activity to meet your specific needs, at least on an initial basis.
If you answered PAR-Q accurately, you have reasonable assurance of your present suitability for:
A graduated exercise programme A fitness appraisal
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start29 Dec 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Model description
- Two groups with randomization, Assignment: Brisk walking
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmed Awan, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925115
- Sponsor's protocol ID
- REC/00930 Salman khan
- Status last verified
- Jun 2021
- First submitted
- 12 Mar 2021
- Last updated
- 14 Jun 2021
- 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity on Academic Stress While Controlling the Confounding Variables
- ClinicalTrials.gov ID
- NCT04925115
- Acronym / sponsor ID
- REC/00930 Salman khan
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 14 Jun 2021 (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.
The study is designed to determine the effectiveness of moderate physical activity on academic stress with controlling and observing on confounding variables.
Detailed description
Now a days, modern time, new researches increased knowledge of researchers on physical activity and its effect on academic stress. Literature search shows to reduce academic stress among people all types of physical activities were effective and useful. Particularly moderate level of physical activity like brisk walking was significantly associated with academic stress, as compare to hard and light physical activities. Many Studies and research was available on the effectiveness of physical activities and found effective for dealing with academic stress but these were single centered and lacking control on confound variables observation, For example, Age, BMI, Socio-economic status, Semester pressure, Curriculum burden, depression, anxiety ,stress , demographics etc were absent in previous studies plus the available research is partial, includes only females. This research will be impartial and free from gender discrimination. Both male and female students will be taken in consideration for test and a multi-centered study will be conducted focusing on the confounding variables to determine the effectiveness of physical activity on academic stress with controlling variables is the recommendation of this research
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups with randomization, Assignment: Brisk walking
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Brisk walkingInterventional group: 1. Warm up and cool down (10 minutes before physical activity) 2. Brisk walking ( 30 minutes each session for 5 days in a week) 3. Week 1 to week 6 same protocol |
| Control group | No intervention | –Routine activity of daily life |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants falling in this category would be recruited into the study.
- Moderate academic stress
Key exclusion criteria (19 listed)
- Participant falling in this category would be excluded from the study.
- Physical Disability
- Acute infection
- Chronic infection
- Acute inflammation
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 |
|---|---|---|
| Brisk walkingAlso: Moderate physical activity* Warm up and cool down (10 minutes before physical activity) * Brisk walking ( 30 minutes each session for 5 days in a week) | Other | Interventional group |
Primary outcome
Academic Stress scale
Time frame: 6 weeks
Academic Stress will be measured through 40 item scale (Academic Stress scale). It will be used during survey for inclusion criteria, This scale consists of 40 items describing the stress in your institution/ college life from the various sources.
Perceived stress scale
Time frame: 6 weeks
Perceived stress scale will be measured through 10 questions in this scale ask you about your feelings and thoughts during the last month. In each case, you will be asked to indicate by circling how often you felt or thought a certain way. As 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often
Depression, Anxiety and Stress Scale (DASS21)
Time frame: 6 weeks
Depression, anxiety and stress scale will be measured through 21 items scale. Moderate stress score is : 19-25
Physical Activity Readiness Questionnaire (PAR-Q)
Time frame: 6 weeks
Physical Activity Readiness Questionnaire (PAR-Q) Yes to one or more questions: If you have not recently done so, consult with your doctor by telephone or in person before increasing your physical activity and/or taking a fitness appraisal. Tell your doctor what questions you answered 'yes' to on PAR-Q or present your PAR-Q copy. After medical evaluation, seek advice from your doctor as to your suitability for: Unrestricted physical activity starting off easily and progressing gradually, and Restricted or supervised activity to meet your specific needs, at least on an initial basis. If you answered PAR-Q accurately, you have reasonable assurance of your present suitability for: A graduated exercise programme A fitness appraisal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- 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.
Waqar Ahmed Awan, 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 Brisk walking in people with Stress, 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 19 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 14 Jun 2021. 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 Imran Amjad, PhD (+923324390125, Imran.Amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic Stress scale (time frame: 6 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 14 Jun 2021.