Physical ActivityPANCT03153189
Correlates of Physical Activity With Quality of Life in College Women of Manipal University
An observational study of Physical Activity, run by Manipal University at 1 site in India.
Trial summary
To find out the relationship between physical activity and self-esteem, sleep quality, anxiety \& depression, body fat percentage, quality of life, in college females Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 61 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2017to 1 Jun 2017
- Phase
- Observational
- 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
Study population: Female who all under 18 -25 yr old and are a student of Manipal University.
Who may be able to join
- Female gender
- age group 18-25
- Indian ethnicity
Who cannot join
- Known cardio-respiratory symptoms and musculoskeletal disorders curtailing form physical activity in the last 3 months, known thyroid dysfunction, known anxiety-depression disorders, recent surgery (last 3months), polycystic ovary disease (PCOD), polycystic ovary syndrome (PCOS) \& pregnancy.
Trial locations and contacts
1 site in 1 country.
India1 site
Center for Sport Science Medicine and Research
Udupi, Karnataka, 576014
About this study
Official title: Correlates of Physical Activity With Anthropometric Traits, Mental Health and Quality of Life in College Women of Manipal University
To find out the relationship between physical activity and
- self-esteem,
- sleep quality,
- anxiety \& depression,
- body fat percentage,
- quality of life, in college females
Read the detailed description
- After receiving approval from the Institutional Research Committee and Institutional Ethical Committee clearance.
- Advertisement of the research project will be done via the Head of Department of each faculty of the university
- Subjects will be recruited on a voluntary basis and a written informed consent will be obtained after the research idea is explained.
- Demographics of each participant will be obtained
- Each of the following questionnaires will be administered:
Depression, Anxiety and Stress Scale (DASS-21) Rosenberg Self-Esteem Scale Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Pittsburgh Sleep Quality Index (PSQI) International Physical Activity Questionnaire-Long Form (IPAQ)
- Conditions
- Physical Activity
- Keywords
- PA,menatal health,QOL
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire-Long Form (IPAQ)
score of the questionnaire in MET/hr
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 May 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiral Chauhan, Manipal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153189
- Sponsor's protocol ID
- REF/2017/05/014211
- Acronym
- PA
- Status last verified
- Jun 2017
- First submitted
- 12 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anjana RM, Pradeepa R, Das AK, Deepa M, Bhansali A, Joshi SR, Joshi PP, Dhandhania VK, Rao PV, Sudha V, Subashini R, Unnikrishnan R, Madhu SV, Kaur T, Mohan V, Shukla DK; ICMR- INDIAB Collaborative Study Group. Physical activity and inactivity patterns in India - results from the ICMR-INDIAB study (Phase-1) [ICMR-INDIAB-5]. Int J Behav Nutr Phys Act. 2014 Feb 26;11(1):26. doi: 10.1186/1479-5868-11-26.
PubMed 24571915Rimer J, Dwan K, Lawlor DA, Greig CA, McMurdo M, Morley W, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD004366. doi: 10.1002/14651858.CD004366.pub5.
PubMed 22786489Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002 Sep;53(3):737-40. doi: 10.1016/s0022-3999(02)00330-6.
PubMed 12217446
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Physical Activity With Anthropometric Traits, Mental Health and Quality of Life in College Women of Manipal University
- ClinicalTrials.gov ID
- NCT03153189
- Acronym / sponsor ID
- PA / REF/2017/05/014211
- Conditions
- Physical Activity
- Keywords
- PA,menatal health,QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Manipal UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 15 May 2017 (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 find out the relationship between physical activity and
- self-esteem,
- sleep quality,
- anxiety \& depression,
- body fat percentage,
- quality of life, in college females
Detailed description
- After receiving approval from the Institutional Research Committee and Institutional Ethical Committee clearance.
- Advertisement of the research project will be done via the Head of Department of each faculty of the university
- Subjects will be recruited on a voluntary basis and a written informed consent will be obtained after the research idea is explained.
- Demographics of each participant will be obtained
- Each of the following questionnaires will be administered:
Depression, Anxiety and Stress Scale (DASS-21) Rosenberg Self-Esteem Scale Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Pittsburgh Sleep Quality Index (PSQI) International Physical Activity Questionnaire-Long Form (IPAQ)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female who all under 18 -25 yr old and are a student of Manipal University.
Key inclusion criteria (3 listed)
- Female gender
- age group 18-25
- Indian ethnicity
Key exclusion criteria (1 listed)
- Known cardio-respiratory symptoms and musculoskeletal disorders curtailing form physical activity in the last 3 months, known thyroid dysfunction, known anxiety-depression disorders, recent surgery (last 3months), polycystic ovary disease (PCOD), polycystic ovary syndrome (PCOS) \& pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Physical Activity Questionnaire-Long Form (IPAQ)
Time frame: immediate
score of the questionnaire in MET/hr
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 2 Jun 2017.
- Results publication: PubMed 24571915Anjana RM, Pradeepa R, Das AK, Deepa M, Bhansali A, Joshi SR, Joshi PP, Dhandhania VK, Rao PV, Sudha V, Subashini R, Unnikrishnan R, Madhu SV, Kaur T, Mohan V, Shukla DK; ICMR- INDIAB Collaborative Study Group. Physical activity and inactivity patterns in India - results from the ICMR-INDIAB study (Phase-1) [ICMR-INDIAB-5]. Int J Behav Nutr Phys Act. 2014 Feb 26;11(1):26. doi: 10.1186/1479-5868-11-26.
- Results publication: PubMed 22786489Rimer J, Dwan K, Lawlor DA, Greig CA, McMurdo M, Morley W, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD004366. doi: 10.1002/14651858.CD004366.pub5.
- Results publication: PubMed 12217446Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002 Sep;53(3):737-40. doi: 10.1016/s0022-3999(02)00330-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by Manipal University at 1 site in India.
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 3 inclusion and 1 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 2 Jun 2017. 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 India. 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?
International Physical Activity Questionnaire-Long Form (IPAQ) (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153189, which also lists 3 linked publications.
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 2 Jun 2017.