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临床试验/CTRI/2025/08/093789
CTRI/2025/08/093789尚未招募2 期

Effects of unsupervised aerobic and resistance training on fat mass reduction, physical function and quality of life in patients with sarcopenic obesity - a randomized clinical trial

Nopany Institute of Healthcare Studies1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Skeletal Muscle Index

研究概览

简要总结

Sarcopenic obesity, characterized by the coexistence of reduced muscle mass and increased fat mass, is an emerging health concern with significant implications for physical function, metabolic health, and quality of life in older adults. Its prevalence is steadily rising worldwide due to aging populations, sedentary lifestyles, and obesity epidemics. This dual burden not only increases the risk of disability but also limits independence and daily functioning.

Methodology: The present randomized clinical trial will evaluate the effects of unsupervised aerobic and resistance exercise on fat mass reduction, physical function, and quality of life in patients with sarcopenic obesity. Eligible participants will be recruited from physiotherapy clinics through screening based on diagnostic criteria for sarcopenic obesity, including assessment of body composition, strength, and functional capacity. After recruitment, participants will be randomly allocated into two intervention groups,with each group (n=20): Group A will be unsupervised group and Group B will be supervised group, both performing aerobic and resistance exercises. Both groups will be provided with structured, exercise protocols, to be performed for 5 times a week for 8 weeks.

Statistical analysis: The statistical analysis will be performed using SPSS software version 30.0. The primary analysis will be done using descriptive statistics to analyze demographic data. Pre ( baseline) and post ( 8 weeks) intervention data will be collected. Within-group changes will be evaluated using paired t-tests and between- group differences will be analyzed using independent t-tests. A p-value less than 0.05 will be considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Low Skeletal Muscle Index, with less than 10.2 kg/m2 in men and less than 8.3 kg/m2 in females 2.Increased Percentage Body Fat: more than 29.7 percentage in men and more than 37.2 percentage in women.

排除标准

  • Patients response as "YES" to any of the questions in PARQ & You Questionnaire
  • Non- ambulatory patients.

结局指标

主要结局

Skeletal Muscle Index

时间窗: 8 weeks

Percentage Body Fat

时间窗: 8 weeks

Waist Circumference

时间窗: 8 weeks

Hand Grip Strength

时间窗: 8 weeks

次要结局

  • Physical functional capacity(Quality of Life)

研究者

发起方
Nopany Institute of Healthcare Studies
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Koushiki Kolay

Nopany Institute of Healthcare Studies

研究点 (1)

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