跳至主要内容
临床试验/NCT06293573
NCT06293573进行中(未招募)不适用

Comparative Effectiveness of Whole- Body Vibration and Aerobic Training Among Egyptian Elderly With Sarcopenia

Cairo University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
84
试验地点
2
主要终点
Muscle Mass

研究概览

简要总结

To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly.

详细描述

Participants will be assigned randomly into two groups of equal number (study group A and study group B ) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects.

c- Subject selection 84 patients with sarcopenia will participate in this study and will be divided randomly into three equal groups with 28 participants in each group.

d- Groups: Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.

Group C (Control Group): will receive conventional progressive resistance exercises and diet modification life style.

During the study, the participants will receive study information form, instructions and signed the consent form.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be assigned randomly into three groups of equal number (study group A, study group B, and group C) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients age older than 60 years
  • patients with Skeletal muscle index (SMI) below 8.87 kg/m2 and 6.42 kg/m2 in males and females, respectively.
  • patients with hand grip strength below < 27 kg in men and < 16 kg in women.
  • patients with no regular exercise habit for more than 3 months .
  • patients with gait speed > 0.8 m/s.
  • patients with proper conscious and cognition that will be detected by using Mini Mental State Examination(scores > 21).

排除标准

  • acute injury. 2- severe heart diseases. 3- pacemaker. 4-history of orthopedic surgery of the lower limbs and/or fracture less than 1 year earlier.
  • .5 - inability to walk without assistance. 6-neurological diseases or acute conditions that would interfere with testing and training.
  • 7-patients with improper conscious and cognition that will be detected by using Mini Mental State Examination(scores < 21).
  • 8- patients who cannot exercise at all due to conditions like deep vein thrombosis or blood clotting issues.
  • 9- patients with severe illnesses that influence assessments and interventions, such as those with disabilities or musculoskeletal conditions (such as fracture, dislocation, osteoporosis, and rheumatoid arthritis).
  • 10- People with major spinal conditions or surgical histories, such as cauda equina syndrome, tumor, vertebral fracture, inflammatory joint disease, spondylolisthesis, and ankylosing spondylitis.
  • Every participant will get a primary checkup to get a full picture of their health, find out if there are any restrictions, and decide whether they can take part in the study.

研究组 & 干预措施

whole body vibration group

Experimental

Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style

干预措施: Whole-body vibration (Device)

whole body vibration group

Experimental

Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style

干预措施: resistance exercises (Other)

aerobic exercise group

Experimental

Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.

干预措施: aerobic exercises (Other)

aerobic exercise group

Experimental

Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.

干预措施: resistance exercises (Other)

conventional resistance exercise group

Active Comparator

Group C (Control Group): will receive conventional progressive resistance exercises and diet modification life style

干预措施: resistance exercises (Other)

结局指标

主要结局

Muscle Mass

时间窗: Muscle mass will be investigated at baseline and after the treatment period of 12 weeks.

Outcome measures included: • Skeletal muscle mass (SMM): will be measured by Bioimpedance analysis using body composition analyzer (InBody Dial H 20b).

muscle strength

时间窗: Muscle strength will be investigated at baseline and after the treatment period of 12 weeks.

will be measured by using calibrated handheld dynamometer (CAMRY EH101).

400 m Walking Test

时间窗: 400 m Walking Test will be investigated at baseline and after the treatment period of 12 weeks.

The 400-meters walk test evaluates a person's stamina and ability to walk. Participants in this test are required to run 20 laps of 20 meters, each lap as quickly as they can, and are permitted up to two rest breaks throughout the test.

Gait Speed test

时间窗: Gait speed test will be investigated at baseline and after the treatment period of 12 weeks.

The 4-m usual walking speed test, which measures speed either manually ,with a stopwatch or instrumentally, with an electronic device, to measure gait timing.

timed Up and Go Test (TUG)

时间窗: Timed Up and Go Test will be investigated at baseline and after the treatment period of 12 weeks.

The TUG test evaluates physical function, individuals will be asked to rise from a standard chair, walk to a marker 3 m away from the chair, turn around, walk back, and sit down again.

Six minute walk test (6MWT)

时间窗: Six Minutes Walk Test will be investigated at baseline and after the treatment period of 12 weeks.

6MWT is used to measure a patient's exercise tolerance. Also it is used to assess aerobic capacity and endurance. Patient is asked to walk at his normal pace for six minutes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Hussien Abdelmotaal Ali Elkadi

Assistant ecturer

Cairo University

研究点 (2)

Loading locations...

相似试验