NCT06460337

Brief Summary

The goal of this randomized clinical trial is to compare the effects of modified Otago and Frenkel's exercises on balance, motor function, fear of fall and quality of life in the geriatric population. The main questions it aims to answer are:

  • How modified Otago and Frenkel's exercises affect balance, motor function, fear of fall and quality of life in the geriatric population?
  • Is there any difference between the effects of these two exercises? Researchers will compare the effects of modified Otago and Frenkel's exercises to see which kind of exercise has superior effects on the mentioned outcomes. Participants will be randomly divided into two groups who will perform their respective exercises for 45 minutes 3 days a week for 8 weeks. Outcomes will be evaluated at the baseline, 4th week and 8th week.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 11, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

BalanceElderlyFrail older adultsHealth-related quality of lifeExercisePhysical activity

Outcome Measures

Primary Outcomes (3)

  • Mini-Best Test

    Mini-BESTest (Balance Evaluation Systems Test) is a brief yet comprehensive clinical assessment designed to evaluate balance, mobility, and fall risk in older adults. Consisting of 14 items, it covers a range of balance-related functions such as anticipatory and reactive postural adjustments, sensory orientation, and dynamic gait movements. Each item is scored from 0 to 2, with higher scores indicating better performance, and the maximum achievable score is 28 points

    8th week

  • Falls Efficacy Scale- International

    The Falls Efficacy Scale-International (FES-I) is a 16-item self-report questionnaire designed to assess an individual's fear of falling during daily activities. Scores range from 16 to 64, with higher scores indicating greater fear of falling. Healthcare professionals commonly use the FES-I to identify individuals at risk of falling and to tailor interventions that improve confidence and reduce the fear of falling.

    8th week

  • Older People's Quality of Life Questionnaire (OPQOL)

    The Older People's Quality of Life Questionnaire (OPQOL) is a self-report tool designed to assess the multidimensional aspects of well-being in older adults. Covering domains such as physical health, psychological well-being, social relationships, and overall life satisfaction, the OPQOL provides a comprehensive understanding of the quality of life for older individuals. It consists of 35 questions with answers on 5-point Likert scale. The total score can range from 35 to 175, with higher scores indicating better quality of life.

    8th week

Study Arms (2)

Modified Otago Exercises

EXPERIMENTAL

It is a series of 17 strength and balance exercises in addition to 30 minutes walk outside the home at the usual pace three times a week.

Other: Modified Otago exercises

Frenkel's Exercises

ACTIVE COMPARATOR

It consists of simple range of motion exercises performed in different positions, i.e., lying, sitting, stride-standing and standing. Exercises are performed slowly emphasizing coordination and precision.

Other: Frenkel's exercises

Interventions

Participants will engage in modified Otago exercise sessions, either individually or in groups, for 45 minutes, thrice weekly over an 8-week period. The program entails moderate-intensity strengthening exercises targeting various muscle groups such as hip extensors, abductors, knee flexors and extensors, inner range quadriceps, ankle plantar flexors, and dorsiflexors, performed at 10 repetitions maximum (RM) with ankle cuff weights ranging from 0.5 to 1 kg. Additionally, balance exercises will be conducted, initially with support and gradually progressing to without support, including knee bends, backwards walking, sideways walking, tandem stance and walk, one leg stance, heel and toe walking, sit-to-stand, stair climbing, stepping over objects, and bending to pick up objects from the floor. Participants are also encouraged to walk outdoors at their usual pace for 30 minutes at least three times weekly.

Modified Otago Exercises

Frenkel's exercise regimen comprises a series of movements performed in lying, sitting, stride standing, and standing positions aimed at improving coordination and motor control. In the lying position, exercises include alternating hip and knee flexion/extensions, hip abduction/adduction, pedaling the lower limbs, and simultaneous movements of hips and knees. These are executed slowly to enhance coordination. In sitting, exercises involve leg stretching, hip flexion with knees flexed or straightened, and transitions from sitting to standing and back. Stride standing exercises focus on weight transfer and sideways walking, while standing exercises encompass walking on marked paths, trunk rotations, 360-degree turns, smaller arcs of hip abduction/adduction and flexion/extension, straight-line walking, and directional changes to simulate real-life obstacles. 3 sets comprising 10 repetitions are performed for each exercise, aiming for motor skill improvement and balance enhancement

Frenkel's Exercises

Eligibility Criteria

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

You may qualify if:

  • Community-dwelling adults of both genders who have experienced a fall at least once in the previous year
  • Minimum Berg Balance score of \>40
  • Able to independently walk and perform everyday activities without any walking aid

You may not qualify if:

  • Unable to walk independently.
  • Previous surgeries related to knee or hip joint replacement.
  • Severe comorbidities such as stroke, unstable coronary artery disease, Parkinson's disease, and epilepsy.
  • Patients with mental illness such as schizophrenia, dementia, and Alzheimer's disease
  • Uncorrected visual, auditory, or vestibular impairments
  • Having limb defects or any physical disability that prevents performing the exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wahla Family Hospital

Pindi Bhattian, Punjab Province, 52180, Pakistan

RECRUITING

Related Publications (2)

  • Jahanpeyma P, Kayhan Kocak FO, Yildirim Y, Sahin S, Senuzun Aykar F. Effects of the Otago exercise program on falls, balance, and physical performance in older nursing home residents with high fall risk: a randomized controlled trial. Eur Geriatr Med. 2021 Feb;12(1):107-115. doi: 10.1007/s41999-020-00403-1. Epub 2020 Nov 25.

    PMID: 33237565BACKGROUND
  • Manko G, Pieniazek M, Tim S, Jekielek M. The Effect of Frankel's Stabilization Exercises and Stabilometric Platform in the Balance in Elderly Patients: A Randomized Clinical Trial. Medicina (Kaunas). 2019 Sep 11;55(9):583. doi: 10.3390/medicina55090583.

    PMID: 31514453BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Wajiha Shahid, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is a single-blinded study, where the researcher who will assess outcomes, will be masked to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be a randomized clinical trial. Through the computerized table generator method of randomization, the selected individuals will be evenly divided into two groups, one undergoing Frenkel's exercises and the other modified Otago exercises.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

March 20, 2024

Primary Completion

September 20, 2024

Study Completion

November 1, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations