NCT07061106

Brief Summary

The objective of the study is to determine the comparative effects of Otago Exercise Program and Kitchen Sink Balance Exercises on strength, fall risk and functional mobility on elderly. This study would include total 56 participants which would be divided into two groups, 28 each. Convenience Sampling will be used and randomly assigned into two groups through sealed envelope method. Intervention Group A received Otago Exercise Program and Group B received Kitchen Sink Balance Exercises. Both groups received intervention for 45 minutes per session, 3 times a week, and for a total of 8 weeks. Assessment was done at the baseline, after 4 weeks and after 8 weeks.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 2, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

Otago, Kitchen Sink, fall risk, strength, functional mobility, Elderly

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale

    BBS is used for assessment of balance and is considered as a gold standard. It consist of 14 simple task and it takes almost 15-20 minutes to complete. Its 0-4 grading scale where 0 means unable and 4 means independent. Overall score is 56 having interpretation of \<20 indicative of wheel chair user, \>20-\<40 walking with assistance and \>40-56 showing independency of patient. On BBS cut-off score of 40 points provided optimal sensitivity of 0.82 and specificity of 0.67.

    8 weeks

  • Short Physical Performance Battery Score Tool (SPPB)

    SPPB is a group of objective assessment tools for balance, lower extremity strength, and functional mobility in older adults (\>65 years of age). The test includes three different domains like walking, sit-to-stand and balance to assess individual's functional mobility. The scoring of this tool range from 0 (worst performance) to 12 (best performance).

    8 weeks

Study Arms (2)

Otago exercise program

EXPERIMENTAL

Group will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions).

Other: Otago exercise program

Kitchen Sink Balance Exercises

ACTIVE COMPARATOR

Group will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions).

Other: Kitchen Sink Balance Exercises

Interventions

Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Intervention Group A received Otago Exercise Program and will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). The Otago Exercise Program is a fall prevention well designed program for older adults. It includes 17 strength and balance exercises and a walking program, which are typically performed three times a week and helps to prevent falls in older adults by strengthening muscles and improving balance. In this study, modified form of Otago would be used that focuses on balance and strengthening exercises.

Otago exercise program

Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Intervention Group B received Kitchen Sink Balance Exercises and will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). Kitchen sink balance exercises are beneficial for improving overall Individual's stability, strength, and coordination. These exercises can be easily integrated into daily routine and it also providing a practical way to enhance balance and overall fitness.

Kitchen Sink Balance Exercises

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals aged 65 and older.
  • Both males and females.
  • Individuals have a score on BBS (21-40)
  • Willingness to participate

You may not qualify if:

  • Individuals with Severe Cognitive Impairment that would impede understanding and following exercise instructions.
  • Individuals having Conditions that contraindicate exercise. (e.g. severe cardiovascular disease)
  • Individuals with psychiatric disorders and malignancies.
  • Individuals Aged less than 65 years.
  • Individuals who are already involve in other balance training program.
  • Individuals who are not willing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Najjat Trust

Rawalpindi, Pakistan

RECRUITING

Study Officials

  • Nadia Azhar, MS-NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Azhar, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 11, 2025

Study Start

February 15, 2025

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations