| CTRI Number |
CTRI/2024/05/067753 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| 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
|
How doing Aerobic exercises impacts how well middle-aged adults sleep and how strong their heart and lung become. |
|
Scientific Title of Study
|
Effects of Aerobic exercises on Sleep quality and Cardio-Respiratory endurance in healthy middle-aged adults- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranali Chandanshiv |
| Designation |
Post Graduate student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
3rd floor Cradio-Respiratory Department
Dr. D. Y. Patil College of Physiotherapy
Dr. D. Y. Patil Vidyapeeth
Pimpri 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7447760763 |
| Fax |
|
| Email |
pranalichandan117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zafar Azeem |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
Outpatient Physiotherapy Department
Consulting suite
Dr D Y Patil College of Physiotherapy
Dr D Y Patil Vidyapeeth
Pune
MAHARASHTRA
411018
India |
| Phone |
9586668118 |
| Fax |
|
| Email |
zafar.azeem@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pranali Chandanshiv |
| Designation |
Post Graduate student |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
3rd floor, Cardio-Resipratory Department
Dr. D. Y. Patil College of Physiotherapy
Dr. D. Y. Patil Vidyapeeth
Pune
MAHARASHTRA
411018
India |
| Phone |
7447760763 |
| Fax |
|
| Email |
pranalichandan117@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D Y Patil College of Physiotherapy
Sant Tukaram Nagar
Pimpri 411018 |
|
|
Primary Sponsor
|
| Name |
Pranali Chandanshiv |
| Address |
Rao Colony
Balaji Park No 1
Talegaon Dabhade 410506 |
| 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 |
| Pranali Chandanshiv |
Dr. D Y Patil College of Physiotherapy |
3rd Floor Cradio-Respiratory Department
Dr. D. Y. Patil College of Physiotherapy
Dr. D. Y. Patil Vidyapeeth
Sant Tukaram Nagar
Pimpri
411018
Pune
MAHARASHTRA |
7447760763
pranalichandan117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with poor sleep quality |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercises |
Aerobic exercise training would be given to subjects in the intervention group for 4 weeks
3 sessions per week. |
| Comparator Agent |
CONTROL GROUP |
Comparator group training for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy Middle aged adults
Participants who answered NO to all questions in PARQ
PSQI scores more than 15 |
|
| ExclusionCriteria |
| Details |
Adults having any self reported or pre diagnosed respiratory problems like
Asthma
Adults having any self reported or pre diagnosed comorbid conditions like
hypertension and diabetes
Adults who are overweight and obese
Participants who are athletic or who play sports on a regular level
Adults with visual or balance issues
Adults suffering from orthopedic problems like knee pain creating difficulty
in walking
Adults with neurological conditions like Stroke
Adults with addictions like smoking |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
2-minute walk test
Pittsburgh Sleep Quality Index (PSQI) |
0 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Studies have shown that insufficient sleep is associated with hormonal changes in the body, including the release of leptin, ghrelin, cortisol, and growth hormone. Hormonal changes may result in reduced tissue insulin sensitivity. These changes have an impact on inappropriate food selection, changes in energy regulation, excessive food intake, and reduced physical activity. Studies on improving sleep quality through physical activity have mixed results. Significant amount of research has investigated the effects of physical activity on sleep. Results generally suggest that physical activity is beneficial for sleep, however it is unclear how large these benefits are. Research suggested that people who are physically active have better sleep quality than those who are not. Other studies found that moderate physical activity does not significantly improve sleep duration, habitual sleep efficiency or sleep disturbances. The current study will examine whether physical activity has any effect on sleep quality and cardio-respiratory endurance
|