Progressive Resistance Exercises Versus Functional Training in Elderly With Risk of Fall.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 39
- Primary Endpoint
- Berg Balance Scale (BBS)
Study Overview
Brief Summary
Study Design: Randomized Clinical Trial Objective: To find the effects of Progressive Resistance Exercises for balance and risk of falls in elderly population.
To find the effects of Functional Training for balance and risk of falls in elderly population.
To compare the effects of Progressive Resistance Exercises and Functional Training for balance and risk of falls in elderly population.
Inclusion Criteria:
Both Males and Female Patients Patients Age 65 years or above Participants with intact cognitive function or mild cognitive impairment who can follow instructions and provide informed consent Individuals medically cleared by their physician to engage in moderate-intensity physical activities, with no unstable medical conditions that could impede participation Participants willing to commit to an 8-week intervention program (3 sessions per week) and attend follow-ups as required.
Exclusion Criteria:
Elderly individuals who are non-ambulatory or unable to perform basic mobility tasks, such as standing or walking independently, even with assistive devices.
Uncontrolled medical conditions such as uncontrolled hypertension, unstable angina, or severe arrhythmias.
Participants with severe musculoskeletal conditions that significantly limit mobility or exercise participation (e.g., severe arthritis, recent fractures, or joint replacements within the last 6 months).
Presence of acute pain or injury that may worsen with physical activity. Individuals with progressive neurological conditions such as Parkinson's disease, stroke with severe residual deficits, or multiple sclerosis that impede safe participation in physical activities.
Group 1: Progressive Resistance Exercises Participants in the Progressive Resistance Training (PRT) group will engage in a structured exercise program designed to progressively increase muscle strength, balance, and overall physical function.
Group 2: Functional Training Participants in the Functional Training (FT) group will engage in exercises that mimic daily activities to improve balance, strength, mobility, and functional independence.
Detailed Description
Study Design: Randomized Clinical Trial Settings: Study will be conducted at Shadman Medical centre and Jinnah Hospital, Lahore.
Duration of Study: The study will take 09 months after the approval of synopsis.
Sample Size:
The calculated sample size using TUG as an outcome measure is 33 in each group after adding 20% dropout the sample size will be 33+6=39 in each group.
Z1-α/2 Level of significance=95% µ1 Mean change in Group 1= 13 µ2 Mean change in Group 2= 16.7 s1 Standard deviation in group 1= 6.6 s2 Standard deviation in group 2= 3.6 Z1-β power of the study= 80% n sample size in a group= 33 After adding 20% drop out 33+6= 39 in each group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The study will implement single-blinding, where outcome assessors will remain unaware of group assignments to reduce assessment bias. Participants and session supervisors will not be blinded due to the nature of the interventions.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Both Males and Female Patients
- •Patients Age 65 years or above
- •Participants with intact cognitive function or mild cognitive impairment who can follow instructions and provide informed consent
- •Individuals medically cleared by their physician to engage in moderate-intensity physical activities, with no unstable medical conditions that could impede participation
- •Participants willing to commit to an 8-week intervention program (3 sessions per week) and attend follow-ups as required.
Exclusion Criteria
- •Elderly individuals who are non-ambulatory or unable to perform basic mobility tasks, such as standing or walking independently, even with assistive devices.
- •Uncontrolled medical conditions such as uncontrolled hypertension, unstable angina, or severe arrhythmias.
- •Participants with severe musculoskeletal conditions that significantly limit mobility or exercise participation (e.g., severe arthritis, recent fractures, or joint replacements within the last 6 months).
- •Presence of acute pain or injury that may worsen with physical activity. Individuals with progressive neurological conditions such as Parkinson's disease, 15 stroke with severe residual deficits, or multiple sclerosis that impede safe participation in physical activities.
Arms & Interventions
Group 1
Progressive Resistance Training
Intervention: Progressive Resistance Training (Other)
Group 2
Functional Training
Intervention: Functional Training (Other)
Outcomes
Primary Outcomes
Berg Balance Scale (BBS)
Time Frame: from enrollment to the end of treatment at 8 weeks
The BBS will evaluate static and dynamic balance through 14 functional tasks, such as standing, reaching, turning, and stepping. Each task is scored on a 5-point ordinal scale (0-4), with a total score of 56. A score of ≤45 will indicate an increased risk of falls, providing a comprehensive measure of postural stability and balance control.
Secondary Outcomes
- Timed Up and Go Test(from enrollment till the end of treatment at 8 weeks)
- Falls Risk Assessment Tool FRAT(From enrollment the end of treatment at 8 weeks)
Investigators
Haleema Imran
Dr.
University of Lahore