| CTRI Number |
CTRI/2016/07/007102 [Registered on: 18/07/2016] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of interval exercises on sleep in older adults |
|
Scientific Title of Study
|
Effect of interval training on sleep quality in geriatric individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashirwad Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Pravara Institute of Medical Sciences, Technologcal Educational Institute of Western Greece |
| Address |
Department of Physiotherapy
Pravara Institute of Medical Sciences
Loni-bk, taluka Rahata, Dist Ahmadnagar, Maharashtra-
Department of Physiotherapy,
TEI of Western Greece.
Psaron 6, Myrtia 25100, Aigio, Greece
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
aashirwad.mahajan@pmtpims.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Khatri |
| Designation |
Princiapl and Professor |
| Affiliation |
Pravara Institute of Medical Sciences, Maharashtra, India. |
| Address |
College of Physiotherapy,
Pravara Institute of Medical Sciences
Loni-bk, taluka Rahata, District Ahmadnagar, Maharashtra, India
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
principal.cpt@pmtpims.org |
|
Details of Contact Person
Public Query
|
| Name |
Aashirwad Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Technologcal Educational Institute of Western Greece |
| Address |
Department of Physiotherapy,
Pravara Institute of Medical Sciences
Loni-bk, taluka Rahata, Dist Ahmadnagar, Maharashtra
Department of Physiotherapy,
TEI of Western Greece.
Psaron 6, Myrtia 25100, Aigio, Greece
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
aashirwad.mahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Euphrates Erasmus Mundus scholarship programme Lot 2 Action 13 by European Union |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences, Loni-bk, Taluka Rahata, District Ahmadnagar, Loni-413736, Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Technological Educational Institute of Western Greece |
1, Megalou Alexandrou, Patras 26334, Greece |
|
|
Countries of Recruitment
|
Greece
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aashirwad Mahajan |
Pravara Institute of Medical Sciences |
Pravara Institute of Medical Sciences, Loni-bk, Tal Rahata, Dist Ahmadnagar, Loni-413736, Maharashtra, India
Ahmadnagar
MAHARASHTRA |
9970723448
aashirwad.mahajan@pmtpims.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, PIMS-DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
N/A |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interval training |
Exercise intervention given on bicycle ergometer with heart rate monitoring for 8 weeks.
Frequency 3 times in a week, 1 session per day total duration 8 weeks.Intensity given at 65 percent of maximum heart rate for 3 minutes and 85 percent of maximum heart rate for 1 minute. Maximum heart rate calculated by Inbar method. Total 8 repeated bouts of consecutive 4 minutes of cycling.
Duration of 1 interval training session is 30 to 35 minutes preceded and followed by warm up and cool down session of approximately 5 to 10 minutes each. So total duration of 1 session is approximately 40 to 50 minutes. |
| Comparator Agent |
sleep hygiene techniques |
techniques to improve sleep hygiene given in the form of a handout and monitored accordingly. These instructions for sleep hygiene followed by participant for 8 weeks daily. Followup for the same taken every other day and with the help of sleep diary to be filled by the participant |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Complaining of difficulty initiating or maintaining sleep
Scoring greater than 5 on Pittsburgh Sleep Quality Index
Screened by physician for participation in physical activity
|
|
| ExclusionCriteria |
| Details |
Participants with impaired cognitive function.
Patients with uncontrolled hypertension.
Patients having unstable angina
Participants with severe cardiovascular abnormality.
Participants with severe Respiratory disorders.
Participants with severe musculoskeletal disorders.
Participants with neurological disorders
Participants with psychiatric disorders
average alcohol intake greater than 3 drinks per day
and nonsmoker
caffeine consumption greater than
300 mg per day.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pittsburgh Sleep quality Index for measuring sleep quality
3. Polysomnography sleep variables: Total sleep time, Sleep onset latency, Sleep efficiency, Wake after sleep onset, Percentages of Stage 1 and Stage 2 sleep, Slow wave sleep, REM sleep percentage, |
Before and after 8 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Short form 12 questionnaire for Quality of life
|
Before and after 8 weeks of intervention
|
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="5"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2017 |
| Date of Study Completion (India) |
26/02/2019 |
| Date of First Enrollment (Global) |
18/07/2016 |
| Date of Study Completion (Global) |
30/05/2017 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2 publications
1)Mahajan A, Mahajan S, Tilekar S. A Pilot Randomized Controlled Trial of Interval Training and Sleep Hygiene for Improving Sleep in Older Adults. Journal of Aging and Physical Activity. 2021 Apr 9;1(aop):1-0
2)Mahajan A, Koutsojannis C, Theodoritsi M, Pouliasi K, Tsepis E, Khatri S, Kulkarni N. Preliminary extent of poor sleep quality and its risk factors in Greek older adults. IJAR. 2017;3(4):392-7. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Primary purpose of the protocol is to find out whether an interval training program along with sleep hygiene will produce greater clinically significant improvement on sleep quality than sleep hygiene alone in geriatric individuals
|