Protocol summary

Study aim
To investigate the effectiveness of a multimodal intervention program (including nutritional modification, physical exercise, biomechanical modification, psychological interventions, and drug management) to improve health in the elderly.
Design
Each of the intervention and the control group will consist of 40 subjects. The intervention group will receive medication counseling for polypharmacy, an exercise program in accordance with international standards, biomechanical correction with orthoses, nutritional correction, and psychological counseling, and the control group will receive only routine medical care.
Settings and conduct
Tehran selected elderly care centers
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Age ≥ 65 years - Ability to walk independently with or without a mobility aid - Score of 21 to 40 on the Berg Balance Scale, indicating moderate balance - Written informed consent to participate in the study Exclusion criteria: - Severe neurological disorders (such as stroke or advanced Parkinson's) - Moderate to severe dementia (MMSE score less than 20) - Severe musculoskeletal problems - Inability to participate in interventions for more than 2 weeks
Intervention groups
The intervention group will undergo a multimodal intervention program that includes the following: 1. Nutritional modification and Supplement prescription 2. Selected physical exercises (strength, balance, functional) 3. Biomechanical modification (posture correction, footwear, mobility aids) 4. Medication management (focusing on polypharmacy) 5. Psychological interventions including CBT) The control group will receive usual care.
Main outcome variables
Balance score of Berg test; Mobility score (TUG); Nutritional status; Polypharmacy index; Depression and anxiety; lower limb strength; Gait speed

General information

Reason for update
Acronym
MFI
IRCT registration information
IRCT registration number: IRCT20251102067858N1
Registration date: 2025-11-23, 1404/09/02
Registration timing: prospective

Last update: 2025-11-23, 1404/09/02
Update count: 0
Registration date
2025-11-23, 1404/09/02
Registrant information
Name
Farhad Moradi Shahpar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0228
Email address
f_moradishahpar@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-06, 1404/09/15
Expected recruitment end date
2026-01-05, 1404/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of a Multifaceted Intervention Program Including Activity and Balance Exercises, Nutritional, Biomechanical, Pharmacological, and Psychological Components on Improving Balance in Older Adults
Public title
Multifaceted Intervention on Balance in Older Adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Age ≥ 65 years- Ability to walk independently with or without a mobility aid- Score of 21 to 40 on the Berg Balance Scale, indicating moderate balance- Written informed consent to participate in the study
Exclusion criteria:
- Severe neurological disorders (such as stroke or advanced Parkinson's) Moderate to severe dementia (MMSE score less than 20) Severe musculoskeletal problems Inability to participate in interventions for more than 2 weeks
Age
From 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after assessing the inclusion and exclusion criteria, participants will be randomly assigned to two groups: intervention and control. The randomization method will be performed in four-block randomization using Random Allocation Software (RAS). To avoid bias in allocation, the randomization process will be performed by an individual independent of the research team.
Blinding (investigator's opinion)
Single blinded
Blinding description
For blinding, due to the nature of the intervention, blinding of participants is not possible. However, the outcome assessors and the data analyst will be blinded to the group allocation (single-blind study design). To ensure that blinding is maintained, the groups will be coded and will only be opened after the statistical analysis is completed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Poorsina ave., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2025-07-13, 1404/04/22
Ethics committee reference number
IR.TUMS.NI.REC.1404.022

Health conditions studied

1

Description of health condition studied
balance impairment in elderly
ICD-10 code
R26.81
ICD-10 code description
Unsteadiness on feet

Primary outcomes

1

Description
Berg Balance Scale
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
14 items in Berg balance Test

2

Description
Time of Timed Up and Go Test
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
Time taken by the participant to cover the 3-meter distance

3

Description
Nutritional situation in Mini Nutritional Assessment
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
Short Form Nutrition Assessment Score

4

Description
Score of the Medication Appropriateness Index
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
Score from the quality of medication use assessment for the elderly based on the Medication Appropriateness Index

5

Description
Level of Anxiety and Depression
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
The scores of Geriatric Depression Scale and Geriatric Anxiety Inventory tests

6

Description
The strength of lower limbs
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
30 -Second Chair Stand Test score

7

Description
The Speed of Gait
Timepoint
Pre-test before intervention and at the end of 12 weeks intervention
Method of measurement
Average gait speed of the participant on the 4-meter path

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

2

Description
Control group:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashemi Care centers for the elderly in Kahrizak
Full name of responsible person
Mohsen Salman Nedjad
Street address
Hakimzadeh Blvd, Qom road,
City
تهران
Province
Tehran
Postal code
1819117536
Phone
+98 21 5652 5804
Email
info@kahrizakcharity.com
Web page address
https://kahrizakcharity.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
Corner of Qods Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Fax
+98 21 8163 3047
Email
vcr@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Moradi Shahpar
Position
Researcher at Sports Medicine Research Center
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411734141
Phone
+98 21 8863 0228
Email
drfmoradi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Moradi Shahpar
Position
Reseacher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Research Center, No 7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411734141
Phone
+98 21 8863 0228
Fax
Email
f_moradishahpar@sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Moradi Shahpar
Position
Reseacher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Research Center, No 7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411734141
Phone
+98 21 8863 0228
Fax
Email
f_moradishahpar@sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main research findings will be published in the form of an article.
When the data will become available and for how long
After the results are published, up to two years later
To whom data/document is available
Employees at academic institutions and well-known researchers
Under which criteria data/document could be used
For verification by the editor of the journal or journals in which the articles are published and for researchers who wish to conduct further research in this field.
From where data/document is obtainable
Email the principal investigator.
What processes are involved for a request to access data/document
After receiving the email, it is discussed with the research center's research council and, with the center's permission, the information is made available to the researchers by removing the subjects' names and carrying out other legal and ethical considerations.
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