Progressive Resistance Exercises Versus Functional Training in Elderly With Risk of Fall.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1
Progressive Resistance Training
干预措施: Progressive Resistance Training (Other)
Group 2
Functional Training
干预措施: Functional Training (Other)
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: 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.
次要结局
- 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)
研究者
Haleema Imran
Dr.
University of Lahore