NCT05781776

Brief Summary

Fall occurrences and the associated risk of injury are debilitating and major health concerns in the older population. Several interventions have been investigated and implemented to address the needs of balance impairments and to reduce the increased risk of falls. This study aimed to compare the effectiveness of the Otago exercise program (OEP) and gaze stability exercises (GSE) on balance and the risk of falls in older adults residing at an old age home facility. 30 elderly participants were equally and randomly divided into two groups: Group OEP received the OEP and group GSE received GSE for eight weeks (thrice a week). In addition, both groups also performed core muscle-strengthening exercises. The Berg balance scale (BBS) and the Fall efficacy scale-International (FES-I) were the outcome measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 12, 2023

Last Update Submit

March 23, 2023

Conditions

Keywords

Berg balance scaleFall efficacy scale-InternationalRehabilitationExercisesOlder Adults

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    This tool encompasses both static and dynamic balance components across 14 different activities (5 static and 9 dynamic) performed by the patient graded on varying difficulty levels for different balance conditions (sitting balance, standing up, turning around, walking on an even surface, walking on steps, and while changing body position). The BBS utilizes an ordinal grading on a 5-point scale (0-4) to rate the 14 task items, producing a global score of 56 with the lower score assigned to poor performance (score-0) and a greater score representing the better outcomes (score-4).

    8 weeks.

  • Fall efficacy Scale- International (FES-I)

    The FES-I form consists of 16 items related to various functional activities. The participant is asked to rate the level of each activity on a 4-point Likert scale. A higher score implies a greater fear of falls and lower score imply better outcomes.

    8 weeks.

Study Arms (2)

Otago exercise program group

EXPERIMENTAL

Participants performed Otago exercise program and core muscle strengthening exercises for eight weeks (thrice a week).

Other: Otago exercises and core strengthening

Gaze stability exercises group

ACTIVE COMPARATOR

Participants performed Gaze stability exercises and core muscle strengthening exercises for eight weeks (thrice a week).

Other: Gaze stability exercises and core strengthening

Interventions

Otago exercise program consisted of strengthening and balance exercises. The strengthening exercises focus on major lower limb muscles. Progression of exercises was done by increasing the duration and then intensity. Balance exercises involved knee bends, backward walking, walking, and turning around, sideways walking, tandem stance (heel to toe), tandem walk (heal to toe walk), one leg stand, heel walking, toe walk, heel to toe walking backward, sit to stand and stair walking. Balance exercises progressed with varying levels of support depending on their balance and confidence. The individuals repeated each exercise 10 times.

Otago exercise program group

The exercise protocol in Gaze Stability exercises included adaptation exercises and substitution exercises. In adaptation exercises, individuals performed rapid, active head rotations while watched a visual target with the target remaining stationary. Substitution exercises, individual performed eye-head movements between targets with the goal of seeing clearly during the task. That target moved in the opposite direction of head movement. Adaptation exercises included: Horizontal and vertical (stationary target) viewing exercises done with a near target, sitting. Horizontal and vertical (stationary target) viewing exercises done with near and far targets (6-10 feet), sitting. Horizontal and vertical (stationary target) viewing exercises were done with near and far targets, standing.

Gaze stability exercises group

Eligibility Criteria

Age65 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants were independent in ambulation
  • They were performing activities of daily living independently
  • They had impaired balance having Berg Balance Scale (BBS) score between 35-45
  • They had dynamic Gait Index score between 11-19
  • They had mini-mental status exam scores \> 22

You may not qualify if:

  • severe vision or hearing impairment,
  • neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson's disease, etc.,
  • muscular disorders which limit functional activity (Osteoarthritis, Rheumatoid arthritis, etc.),
  • taking medications that affect balance,
  • severe cardiovascular conditions,
  • recent Lower limb injury or Surgery,
  • obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

Related Publications (1)

  • Kp N, D A, Nawed A, Nuhmani S, Khan M, Alghadir AH. Comparison of effects of Otago exercise program vs gaze stability exercise on balance and fear of fall in older adults: A randomized trial. Medicine (Baltimore). 2024 Jun 7;103(23):e38345. doi: 10.1097/MD.0000000000038345.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Masood Khan, M.P.Th.

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two arms pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 23, 2023

Study Start

November 1, 2020

Primary Completion

February 10, 2021

Study Completion

June 21, 2021

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations