| CTRI Number |
CTRI/2020/12/029766 [Registered on: 14/12/2020] Trial Registered Prospectively |
| Last Modified On: |
10/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Aerobics On Attention and Executive Function In Normal Adults |
|
Scientific Title of Study
|
Effect Of Aerobics On Attention and Executive Function In Normal Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shriya Vijay Medhi |
| Designation |
Post-Graduate student |
| Affiliation |
Dr.D.Y.Patil College Of Physiotherapy, Pune |
| Address |
Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9923127237 |
| Fax |
|
| Email |
svmedhi1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College Of Physiotherapy, Pune |
| Address |
Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shriya Vijay Medhi |
| Designation |
Post-Graduate student |
| Affiliation |
Dr.D.Y.Patil College Of Physiotherapy, Pune |
| Address |
Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9923127237 |
| Fax |
|
| Email |
svmedhi1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Vidyapeeth, Pune. |
|
|
Primary Sponsor
|
| Name |
Shriya Medhi |
| Address |
Dr.D.Y.Patil College Of Physiotherapy , Dr.D.Y.Patil Institute, Pimpri,Pune. 411018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shriya Medhi |
Dr.D.Y.Patil College Of Physiotherapy |
Dr.D.Y.Patil College Of Physiotherapy OPD, Ground Floor , Dr.D.Y.Patil Institute, Pimpri,Pune. 411018
Pune
MAHARASHTRA |
9923127237
svmedhi1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil Vidyapeeth, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitive Decline |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobics |
V box with rolls, Grape wine, Mambo, Full diamond, Knee Lift, Knee lift ssd, Jaz stretch, Polka, Heel digs, Step touch, Modified Half Jack, Diamond, Hams curls, Lunges.
3 times per week. Total 12 sessions. Each session of 45 minutes. |
| Comparator Agent |
Aerobics, No intervention control group. |
Control group will be told to continue with their regular activities but not to get involved in any new form of exercise.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Normal middle aged individuals; age group 35-60.
2) Both genders.
3) Individuals with Addenbrooke’s Cognitive Examination-ACE III English Indian Version score less than 88.
|
|
| ExclusionCriteria |
| Details |
1) Individuals with neurological conditions like mental retardation, stroke, spinal cord injury.
2)Individuals with uncontrolled hypertension. (Blood pressure: systolic ≥ 140mmhg & diastolic ≥ 90mmhg)
3) Individuals with musculoskeletal conditions like recent fracture, dislocations, contractures, deformities.
4) According to BMI; individuals falling in the criteria of Obese I & Obese II.
5) People who are not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stroop Effect Application, Neuropsychological Assessment Battery Attention Module & Executive Function Module |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DASS, Sleep Quality Scale |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is a cognitive decline with aging. Coordinating the steps with counts (Metronome) makes it more challenging to remember the steps as well as performing it on the correct counts and requires cognitive efforts. Previous study has shown positive long-term effects on mild cognitive impairment. The need of this study is to find the effect of aerobics (dance) on attention and executive function in middle aged normal adults. NULL HYPOTHESIS: There will be no difference in effect of aerobics & control group (no intervention) on attention and executive function in normal adults. ALTERNATIVE HYPOTHESIS: There will be effect of aerobics on attention and executive function in normal adults. Objectives are : 1)To find effect of aerobics on attention using Stroop Effect Application & NAB Attention Module in normal adults. (2)To find effect of aerobics on executive function using NAB battery Executive Function Module in normal adults.(3) To find the effect on attention & executive function in control group. (4)To compare aerobics versus control group (no intervention) on attention & executive function in normal adults. (5)To find factors affecting cognitionPre assessment will be done for attention using Stroop Effect Application & NAB Attention Module. Pre assessment for executive function will be carried out by using NAB Executive Function Module. Random allocation of the individuals into two groups will be done by Chit method. This will be followed by post assessment which will be done using Stroop Effect Application for attention , NAB Attention Module and NAB Executive Function Module for executive function in Group A and Group B.
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