| CTRI Number |
CTRI/2021/09/036738 [Registered on: 22/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Multicomponent exercise program on physical frailty: randomized controlled trial |
|
Scientific Title of Study
|
The Long-Term effects of a Multicomponent exercise program on physical frailty among older adults: 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 |
Bader Alqahtani |
| Designation |
professor |
| Affiliation |
prince Sattam bin Abdulaziz University |
| Address |
prince Sattam bin Abdulaziz University
Department of Health and rehabilitation sciences
King fahad road
Buildeing 11
Room 2061
Alkharj, Saudi Arabia
prince Sattam bin Abdulaziz University
Department of Health and rehabilitation sciences
King fahad road
Buildeing 11
Room 2061
Alkharj, Saudi Arabia
14251
Other |
| Phone |
966580422762 |
| Fax |
|
| Email |
dralqahtaniba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bader Alqahtani |
| Designation |
professor |
| Affiliation |
prince Sattam bin Abdulaziz University |
| Address |
prince Sattam bin Abdulaziz University
Department of Health and rehabilitation sciences
King fahad road
Buildeing 11
Room 2061
Alkharj, Saudi Arabia
prince Sattam bin Abdulaziz University
Department of Health and rehabilitation sciences
King fahad road
Buildeing 11
Room 2061
Alkharj, Saudi Arabia
14251
Other |
| Phone |
966580422762 |
| Fax |
|
| Email |
dralqahtaniba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bader Alqahtani |
| Designation |
professor |
| Affiliation |
prince Sattam bin Abdulaziz University |
| Address |
prince Sattam bin Abdulaziz University
Department of Health and rehabilitation sciences
King fahad road
Buildeing 11
Room 2061
Alkharj, Saudi Arabia
prince Sattam bin Abdulaziz University
Department of Health and rehabilitation sciences
King fahad road
Buildeing 11
Room 2061
Alkharj, Saudi Arabia
14251
Other |
| Phone |
966580422762 |
| Fax |
|
| Email |
dralqahtaniba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prince Sattam bin Abdulaziz
1432 king Fahad Rd, Saudi Arabia, Al-Kharj 16278 |
|
|
Primary Sponsor
|
| Name |
Prince Sattam bin Abdulaziz University |
| Address |
Prince Sattam bin Abdulaziz
1432 king Fahad Rd, Saudi Arabia, Al-Kharj 16278 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Saudi Arabia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bader Alqahtani |
Prince Sattam university hospital |
Second floor room number 203
1869
|
00966580422762
dralqahtaniba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of department of Rehabilitation Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
frailty |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multicomponent exercise program |
Exercise program will include walking,balance, strengthing, flexability exercises.
for 60 min/ 3 times a week, for 12 weeks |
| Comparator Agent |
usual care exercise |
Strengthening, and flexibility exercises
60min/3 times a week, for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects will be included in the study if they were 60 years of age or older, able to ambulate with or without an assistive device, and cognitively intact, which will be measured by the Mini-Mental State Examination |
|
| ExclusionCriteria |
| Details |
Participants were excluded if they were non-frail, or have any acute illness or medical condition that is not stable at the time the study recruitment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fried’s frailty phenotype
|
Baseline measures will be taken directly after including participants. Follow-up measures are taken 3,6, 12 months after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Short Physical Performance Battery (SPPB)
Timed Up and Go (TUG)
Six-minute walk test (6MWT) |
Baseline measures will be taken directly after including participants. Follow-up measures are taken 3,6, 12 months after baseline |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="0"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Frailty has been recognized as a dynamic condition; with appropriate interventions, frailty status can be altered, and older adults can transition between frailty states over the course of their lives. Furthermore, the negative impact frailty has on the lives of older adults makes it critical to intervene to delay or prevent any adverse health outcomes. To decrease the burden of frailty an implantation of proper intervention in early stages is needed. To the best of our knowledge, studies that have examined the long term effect of multicomponent exercise training are lacking. Therefore, our study aims to examined the long term impact of multicomponent exercise program on physical frailty among older adults |