| CTRI Number |
CTRI/2019/08/020773 [Registered on: 19/08/2019] Trial Registered Prospectively |
| Last Modified On: |
24/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study we will compare the effect of two different training protocols on sleep quality and quality of life in older people with sleep disturbance |
|
Scientific Title of Study
|
A Comparison between Effect of Aerobic Training and Resistance Training on Sleep Quality and Quality of Life in Older Adults with Sleep Disturbance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailly Gupta |
| Designation |
Post graduate student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy (Delhi University) |
| Address |
Ground floor OPD, Physiotherapy department, Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar, Delhi 110092
East
DELHI
110092
India |
| Phone |
8802223934 |
| Fax |
|
| Email |
shaillygupta9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshitija Bansal PT |
| Designation |
Associate Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy (Delhi University) |
| Address |
Ground floor OPD, Physiotherapy department, Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar, Delhi 110092
East
DELHI
110092
India |
| Phone |
9810314488 |
| Fax |
|
| Email |
kshitijapatki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shailly Gupta |
| Designation |
Post graduate student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy (Delhi University) |
| Address |
Ground floor OPD, Physiotherapy department, Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar, Delhi 110092
East
DELHI
110092
India |
| Phone |
8802223934 |
| Fax |
|
| Email |
shaillygupta9@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF Amar Jyoti Institute of Physiotherapy, Karkardooma, New Delhi 110092 |
|
|
Primary Sponsor
|
| Name |
Amar Jyoti Institute of Physiotherapy |
| Address |
Karkardooma, Vikas Marg, New Delhi-110092 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shailly Gupta |
Amar Jyoti Institute of Physiotherapy |
Physiotherapy department ground floor OPD, room no.1, Karkardooma Anand Vihar Delhi 110092
East
DELHI |
8802223934
shaillygupta9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board - Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Comparison between Effect of Aerobic Training and Resistance Training on Sleep Quality and Quality of Life in Older Adults with Sleep Disturbance |
In this study we will compare the effects of aerobic training and resistance training on sleep quality and quality of life in older adults with sleep disturbance. All the subjects who meet the inclusion criteria will be divided into two groups. One group will be given resistance training which includes 5 to 7 minutes of warm up, 30 minutes of resistance exercises with breaks in between followed by 5 minutes of cool down period and other group will be given aerobic training which includes 5 to 7 minutes of warm up, 30 minutes of aerobic exercises followed by 5 minutes of cool down period. These sessions will be given for 4 days per week for 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with age 60 years & above,
Individuals scoring more than 5 in Pittsburgh quality of sleep scale,
Both genders,
Individuals who are independent in their daily activities,
Individuals who can read or understand spoken english.
|
|
| ExclusionCriteria |
| Details |
Individuals with any acute medical illness (Unstable Angina, Heart Failure etc),
Individuals with any diagnosed neurological conditions (Stroke, Parkinson),
Any diagnosed severe cardio-respiratory condition,
Recent fractures of upper and lower limb, replacement and any other surgery in last 6 weeks, WOMAC score more than 34 in functional activity subscale,
Uncontrolled Diabetes, Hypertension
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PITTSBURGH SLEEP QUALITY INDEX (PSQI) scale |
this score will be calculated on the Day 1 i.e. first day of intervention and on the 16th day of intervention i.e. last day of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WORLD HEALTH ORGANIZATION -QUALITY OF LIFE INSTRUMENTS (BREF) scale |
this score will be calculated on the Day 1 i.e. first day of intervention and on the 16th day of intervention i.e. last day of the intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2019 |
| Date of Study Completion (India) |
07/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/02/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Sleep is a biologic process that is essential for life and optimal health. Sleep disturbances refers to the disturbance in the sleep cycle and the quality of sleep which is more common in older adults. It can have deleterious short term and long term effects on our body. However, the treatment for sleep disturbance is majorly pharmacological which offers short term effects and has concerns like dependency, have side effects, and long term health risk. The non pharmacological treatment is gaining more attention nowadays. Various studies have reported beneficial effects of Aerobic training and Resistance training on improving the health and also sleep when compared to other non-pharmacological treatment options. But, there is dearth of literature suggesting which out of the two trainings offer better results. so the aim of the study was to compare the effects of Aerobic and Resistance training on sleep quality and Quality of life in older adults having sleep disturbance. 36 subjects who met the inclusion criteria were recruited for the study. They were divided into two groups. Group A received aerobic training. Group B received resistance training. The training was given for 40- 45 minutes a day, 4 days/ week for 4 weeks. Base line and post treatment PSQI and WHOQOL-BREF scores were recorded.Repeated measure ANOVA with Post hoc analysis was done using SPSS software version 16.0. Analysis revealed significant improvement (p<0.05) in PSQI scores within both groups but not between the groups. Post hoc analysis for sleep efficiency, sleep onset latency and sleep duration showed better improvement in resistance training group. Further QoL showed no significant difference between groups for all domains except domain of social relationship. Thus it can be concluded that Resistance and Aerobic training improves both quality of sleep and life. But resistance training has better effect on sleep efficiency, sleep onset latency and sleep duration |