| CTRI Number |
CTRI/2020/10/028211 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
26/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find wether the aerobic exercises with maximum load in patients with overweight will be effective in improving the sleep habits or not. |
|
Scientific Title of Study
|
Effectiveness of Aerobic Interval Training on Sleep Quality in Participants with Obesity: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Darshana Nariya |
| Designation |
PhD Scholar |
| Affiliation |
Nootan College of Physiotherapy |
| Address |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, Mehsana.
Mahesana
GUJARAT
384315
India |
| Phone |
7984809693 |
| Fax |
|
| Email |
darshananariya072@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash M Khatri |
| Designation |
Principal incharge |
| Affiliation |
Nootan College of Physiotherapy |
| Address |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, Mehsana.
Mahesana
GUJARAT
384315
India |
| Phone |
8141184877 |
| Fax |
|
| Email |
physiokhatri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Darshana Nariya |
| Designation |
PhD Scholar |
| Affiliation |
Nootan College of Physiotherapy |
| Address |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, Mehsana.
Mahesana
GUJARAT
384315
India |
| Phone |
7984809693 |
| Fax |
|
| Email |
darshananariya072@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPB Physiotherapy College, Ugat-Bhesan Road, Surat. |
|
|
Primary Sponsor
|
| Name |
Ms Darshana Nariya |
| Address |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, Mehsana, Gujarat-384315 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Subhash Khatri |
Visnagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Darshana Nariya |
SPB Physiotherapy College |
SPB Physiotherapy College, Ugat-Bhesan road, Jahangirabad,randee road, Surat- 395004
Surat
GUJARAT |
7984809693
darshananariya072@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nootan College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobic interval training |
Participants will be given to exercise for 60 second near to full out effort on treadmill (more than or equal to 80% of maximum heart rate-practically it would be like carrying on conversation with difficulty) followed by 60 second of recovery (40 to 50% of maximum heart rate- practically it would be like working hard enough to break a sweat, but still able to carry on a conversation) on treadmill. This will be repeated for 3 days for 3 week. The intervention consists of a total of 9 aerobic interval training sessions (25 minutes/session) |
| Comparator Agent |
aerobic training |
Participants will be given moderate intensity (40 to 50% of HRmax-working hard enough to break a sweat, but still able to carry on a conversation) aerobic exercise (walking on treadmill) for atleast 30 min. per day for 5 days for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having BMI ≥ 30
2. Participants with poor sleep quality: Pittsburgh Sleep Quality Index (PSQI) global score >5
3. Participants having stable cardio-vascular function with Heart rate less than or equal to 100/min; Blood pressure (systolic: less than or equal to 120mmHg, diastolic: less than or equal to 80mmhg)
|
|
| ExclusionCriteria |
| Details |
1. Physical Activity Readiness Questionnaire (PAR-Q): yes to one or more questions
2. Participants having night work during the period in which the intervention takes place
3. Pregnant or breast-feeding subjects
4. Participants who are on steroids, hypnotics, antidepressants or antipsychotics
5. participants who are regularly physically active (self-reported aerobic exercise more than 3 times per week)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pittsburgh Sleep Quality Index (PSQI)
2. Sleep monitoring by Sleep monitoring Device |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Day time Sleepiness (Epworth Sleepiness Scale)
2. Sleep pattern (The sleep diary contains self-reported information about what time they go to bed and get up, as well as the number of awakenings during the night)
3. Fatigue severity (fatigue severity scale)
4. Health-related quality of life (SF-12)
|
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2020 |
| 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="1"
Months="6"
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
|
This study will be a randomized controlled trial investigating the effectiveness of aerobic interval training on sleep quality in participants with obesity that will be conducted in India. Purpose of this study is to find the effectiveness of aerobic interval training on sleep quality in participants with obesity. Any article related to this trial is not yet published. |