- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07380282
Additional Effects of Strength Training With Otago Exercises on Actual and Perceived Balance in Older Adults
This study, titled "Additional Effects of Strength Training with Otago Exercises on Actual and Perceived Balance in Older Adults", explores strategies to reduce fall risks in the elderly. Falls are a major health concern, often causing injuries, loss of mobility, and reduced quality of life. The Otago Exercise Program (OEP) has been proven effective in improving lower-limb strength and balance, but it primarily focuses on these areas without addressing overall muscle strengthening.
The research aims to assess whether integrating additional strength training with OEP can enhance both actual balance (measured through static and dynamic stability tests) and perceived balance (confidence in avoiding falls). Using a randomized controlled trial, 34 participants aged 60 and above will be recruited and divided into two groups: one receiving OEP alone, and the other combining OEP with structured strength training. Tools such as the Berg Balance Scale, Functional Reach Test, Fall Efficacy Scale, and CONFbal Scale will measure outcomes.
The intervention will last eight weeks, with progressive resistance and balance tasks. Findings are expected to demonstrate improved mobility, reduced fear of falling, and greater confidence among participants receiving combined training. This research addresses a significant gap in geriatric rehabilitation and aims to inform cost-effective, evidence-based strategies for fall prevention, ultimately enhancing independence and quality of life in older adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Falls among older adults represent a critical public health issue, often resulting in injuries, loss of independence, and reduced quality of life. Globally, up to 35% of people over 65 experience falls annually, with risk increasing as age advances. The major contributors are muscle weakness and impaired balance, often linked to sarcopenia, an age-related decline in muscle mass and strength. These deficits compromise postural stability, mobility, and coordination, increasing vulnerability to recurrent falls and associated complications.
The Otago Exercise Program (OEP) is a recognized intervention for fall prevention, focusing on lower-limb strengthening and balance training. Evidence shows it reduces fall rates significantly, yet its scope remains limited to balance and limb strength, overlooking broader muscular demands. Integrating structured strength training with OEP may enhance outcomes by improving static and dynamic stability, muscle power, and confidence in daily tasks. Addressing both physical and psychological factors, such an approach can reduce fall-related injuries, foster independence, and improve quality of life in older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults aged 60 years and above.
- Mini-Mental State Examination (MMSE) score of 24 or higher (sufficient cognitive ability to participate).
- Individuals able to ambulate independently or with minimal assistance (e.g., cane).
- Those who have not participated in a structured balance or strengthening program in the past 3 months.
- Participants able to provide informed consent and adhere to the intervention protocol.
Exclusion Criteria:
- Severe musculoskeletal or neurological conditions limiting mobility (e.g., advanced arthritis, stroke with significant residual deficits).
- Sensory disabilities affecting vision, hearing, or vestibular function.
- Structural defects in extremities.
- Fracture in the past year.
- Unstable systemic pathology, recent surgery, or cancer diagnosis/treatment within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Otago with strengthening exercise
The Otago Exercise Program (OEP) is an evidence-based fall-prevention program designed for older adults, focusing on improving strength, balance, and mobility.
It emphasizes lower-limb strengthening of key muscle groups such as the quadriceps, hamstrings, hip abductors, and ankle muscles through exercises like seated leg extensions, heel raises, sit-to-stand, and standing leg curls.
The balance component includes static and dynamic activities such as tandem walking, single-leg stance, sideways walking, backward walking, and stair stepping, with gradual progression to safely challenge postural control.
In this study, strengthening exercises are integrated with the OEP to enhance overall effectiveness.
The program is delivered three times per week, with each session lasting 40-45 minutes over an 8-week period.
This combined intervention aims to improve balance, reduce fall risk, and increase confidence during daily functional activities among older adults.
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The experimental group participated in an 8-week training program, conducted three times per week with 30-45-minute sessions.
Each session began with a 5-10 minute warm-up, including dynamic stretching, marching in place, and joint mobility exercises.
The program included progressive strength and balance training, starting with light or no resistance and gradually increasing to moderate-high intensity (45-75% of 1RM).
Exercises included seated leg extensions, standing leg curls, sit-to-stand, heel raises, step-ups, wall push-ups, and functional movements such as sideways walking, backward walking, and obstacle walking.
Balance training involved static and dynamic tasks, including tandem stance, single-leg stance, functional reach, and dynamic walking with turns.
Exercise intensity and complexity progressed throughout the program while maintaining safe rest intervals.
Each session concluded with a 5-10 minute cool-down, consisting of lower-limb stretching (quadriceps, hamstrings, calves
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Other: Otago
Otago exercise plan is comprisedset of 14 exercises including strengthening and balance exercises.
The strenghtening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes
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The training program was conducted three times a week, with 30-45-minute sessions.
Each session began with a 5-7 minute warm-up (marching in place, ankle circles, shoulder rolls).
During Weeks 1-2, participants performed sit-to-stand, heel raises, and seated knee extensions (2 × 10), along with sideways walking (5 m, 2-3 reps) and static balance progressing from feet together to tandem stance.
In Weeks 3-4, difficulty increased with sit-to-stand (3 × 10), heel-to-toe walking (5 m), backward walking (3-5 m), single-leg stance (10-15 s), and step-ups (2 × 10).
During Weeks 5-6, exercises included wall push-ups, heel raises on a step, dynamic walking with 180° turns, functional reach, and eyes-closed balance tasks.
In Weeks 7-8, advanced balance tasks were added, including weighted sit-to-stand, single-leg stance with arm movements, obstacle walking, higher step-ups, and dynamic tandem walking.
Each session ended with a 5-7 minute cool-down of lower-limb stretching and breathing exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Actual Balance
Time Frame: 8 weeks
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The 1st primary outcome is the improvement in actual balance Berg Balance Scale (BBS) Score range: 0-56 Cut-off values:
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8 weeks
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Functional Reach
Time Frame: 8 Weeks
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Functional Reach Test Measured in centimeters (cm) Cut-off values:
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8 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceived balance
Time Frame: 8 weeks
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: Falls Efficacy Scale - International (FES-I) Score range: 16-64 Cut-off values:
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8 weeks
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Perceived Balance
Time Frame: 8 weeks
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CONFbal scale Cut-off value:
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FUI/CTR/2025/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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