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IRCT20210524051380N1 IRCT 2021-07-03 Shifa Tameer e Millat University Effects of administrated placebo on physical fitness in adolescents with normal weight. PPA(Placebo on Physical fitness in Adolescents) Effects of administrated placebo on physical fitness in adolescents with normal weight. 2021-04-15 anticipated 111 Complete https://irct.ir/trial/56656 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Health service research, Randomization description: The randomization method was used, the participants were assigned in control and experimental group through sealed enveloped method. Procedure of Randomization: No: of Participants=60 Material used: - 60 Envelops - 60 Sheets of properly cut Aluminum paper double the size of the paper. - 60 Sheets of Carbon paper, cut in to appropriate size according to the paper used. Procedure: Step I - A standard sized square paper was taken in which group "A" was marked. In this way 30 papers were prepared marked with "A" and 30 squared shaped paper marked with "B". Step II The sheet of paper on which either A or B was marked were folded to fit the envelop. Step III A sheet of Carbon paper was placed on the top of the folded paper (marked either A or B ) facing the envelop. Step IV Then the sheet of Aluminum foil was wrapped on the carbon paper ( with folded paper inside). Step V All the above prepared were placed in the envelop ( which was completely opaque), the enveloped was then sealed. Step VI In this way 30 envelops of "A" and 30 envelops of "B" were prepared. with a total number of 60 envelops. Step VII - These 60 envelops were then thoroughly shuffled like deck of cards. - The envelopes were then marked with number 1-60. Each participants picked the envelop in order from 1-60 and was given placebo (water or drink) accordingly, Blinding description: The second investigator was blinded to avoid biasness and water was given to control group and placebo to the experimental group by first investigator. N/A Physical Fittness and Motivation. Intervention group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations
public Naima Farooq
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
ISLAMABAD Pakistan 44000 +92 300 5082849 hanfar144@gmail.com Shifa Tameer-e-Millat Univeraity, Islamabad, Pakistan scientific Naima Farooq
house No.144 Street 42 Margalla Town Phase 2 Islamabad
ISLAMABAD Pakistan 44000 +92 300 5082849 hanfar144@gmail.com Shifa Tameer-e-Millat University Pakistan  Healthy Adolescents of Rawalpindi/Islamabad.  Age: 10-19 (According to WHO) both genders, after taking written consent of participants from their parents/ guardians. 10 years 19 years Both  Diagnosed cases of acute or chronic diseases  Adolescent with any deformity or Psychological illness  Family history of sudden cardiac death, comorbidities (Asthma and Diabetes)  History of exercise associated with dizziness, pre-syncope or collapse  Refusal of giving informed consent Placebo Intervention group: To determine pre and post heart rate and level of exertion of placebo in normal weight adolescents between and within the groups. Timepoint: 30 minute interval between pre and post measurements. Method of measurement: Rate of Perceived Exertion Scale (RPE), Digital Pulse oximetry. To determine pre and post physical fitness between and within the groups. Timepoint: 30 minute interval between pre and post measurements. Method of measurement: Physical activity questionnaire for adolescents and children (PAQ-A & PAQ-C), Standing broad Jump test, Sit and reach test, Running 20m, Reduced cooper test. To compare pre and post motivation of normal weight adolescents. Timepoint: 30 minute interval between pre and post measurements. Method of measurement: Physical Activity and Leisure Motivation Scale (PALMS). To determine the physical activity of normal weight adolescents. Timepoint: no interval. Method of measurement: Physical Activity Questionnaire for Adolescent (PAQ-A), Physical Activity Questionnaire for Children (PAQ-C). Nil Approved 2021-04-09 Institutional Review Board & Research Committee (IRB&EC) Shifa International Hospital and Shifa Tam Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University Islamabad Islamabad Pakistan Approved 2021-04-09 Institutional Review Board & Research Committee (IRB&EC) Shifa International Hospital and Shifa Tam Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University ISLAMABAD Islamabad Pakistan