| CTRI Number |
CTRI/2022/09/045598 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| 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 exercise in elderly population with impaired posture. |
|
Scientific Title of Study
|
Effect of an exercise program on physiological parameters and physical performance in geriatric population with impaired posture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy, School of Nursing Science and Allied Health Science, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9650586238 |
| Fax |
|
| Email |
drsuniljmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Singla |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy, School of Nursing Science and Allied Health Science, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
8586976427 |
| Fax |
|
| Email |
dpkasingla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Singla |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy, School of Nursing Science and Allied Health Science, Jamia Hamdard, New Delhi
West
DELHI
110062
India |
| Phone |
8586976427 |
| Fax |
|
| Email |
dpkasingla@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission (UGC)
Bahadur Shah Zafar Marg,
New Delhi - 110002. |
|
|
Primary Sponsor
|
| Name |
University Grants Commission UGC |
| Address |
Bahadur Shah Zafar Marg,
New Delhi - 110002.
011-23604446, 011-23604200 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jamia Hamdard |
MB Road, Hamdard Nagar, New Delhi. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunil |
Jamia Hamdard |
5th Floor, Central Library building, Gate no. 6, Department of Physiotherapy, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI |
9650586238
drsuniljmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impaired Posture |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercise |
Postural correction advice for 30 mins, including 10 mins warm-up and cool down exercise and self-paced walk for 30 mins,5 days a week for 12 weeks. |
| Intervention |
Exercise Intervention |
Exercise training include posture correction exercises, spinal mobility exercise, spinal muscle strengthening exercises, balance training, and breathing exercise. Total duration of exercise is 60 mins including warm-up and cool-down periods, 5 days a week for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. thoracic kyphosis angle greater than 40° on lateral radiograph of spine.
2. age greater than or equal to 60 years.
3. Proficiency in any one language either English or Hindi.
4. no cognitive impairment as determined by Mini-Mental State Examination.
5. can walk independently both on flat surfaces and ascending stairs. |
|
| ExclusionCriteria |
| Details |
1. any sort of chest pain.
2. uncontrolled hypertension; high resting pulse or respiratory rate; unstable asthma or chronic obstructive pulmonary disease.
3.unable to hear and follow the commands.
4.unable to attend in-person classes.
5.history of surgery of knee or shoulder joints.
6.history of severe osteoporosis and Vitamin D deficiency.
7.history of hemiparesis or paraparesis.
8.history of vertigo
9.history of any progressive neurogenic or myopathic disorder that known to impair motor functions.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cobb’s Angle, Tragus to Wall Distance, Limit of Stability (LOS), Center Of Pressure (COP), Number of Falls, Cadence, Step Length and Stride Length, Hand Grip Strength, Muscle Strength, Body Mass Index, Blood Pressure, Breathing Rate, Heart Rate, Oxygen Saturation, Pulmonary functions, Chest Expansion, Waist-To-Hip Ratio, Number of Vertebral Fractures, Physical Performance, and Health-related Quality of life. |
1st Week and 9th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Glucose level |
1st Week and 9th Week |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
22/09/2022 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to find out the impact of an exercise program in improving posture, balance, gait, muscle strength, and other physiological parameters like body mass index, waist- to-hip ratio, blood pressure, heart rate, oxygen saturation, respiratory rate, and chest expansion. Another aspect of this study is to improve physical performance and quality of life in the geriatric population with impaired posture. The exercise has a potential role in improving posture, balance, gait, muscle strength, pulmonary functions, and quality of life in subjects with impaired posture. This study will be the first of its kind which will address different parameters of health in the Indian elderly population affected with impaired posture. |