跳至主要内容
临床试验/CTRI/2019/09/021190
CTRI/2019/09/021190尚未招募不适用

Strength training of plantar flexor muscle for balance and quality of life in type II Diabetes population in the age group of 40-60 years

Vaishali Ingole1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1.Plantar flexor strength: maximum voluntary contraction.

研究概览

简要总结

This study is interventional study in which strength of plantar flexor muscle will be assessed in subjects with type II Diabetes Mellitus aged 40-60 years. Total 40 subjects will be recruited for this study. Control and interventional group will have 20 subjects each. Plantar flexor muscle strengthening adjunct to aerobic exercise will be given to experimental group and aerobic exercise will be given to control group for 4 weeks. Pre and post assessment of outcome measures will be done. Data will be statistically analysed.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Subject diagnosed with Type II Diabetes Mellitus.
  • •Duration of Type II Diabetes Mellitus of >5years.
  • •HbA1C< 8-9%with in 3 months.
  • •Age group of 40-60 years.
  • •BMI – 18 to 29.9 Michigan Neuropathy Screening Instrument score >8.

排除标准

  • •Osteo-articular deformities Pain at hip- knee- ankle joints History of any nerve injury neuropathy, or peripheral nerve injury Acute neuritis with or without use of medication History of diagnosed foot ulcers, 6 months before the study Total or partial amputation of feet Muscular disorders or rheumatoid arthritis Subjects with visual and auditory impairment.
  • •Walking with assistive devices Varicose veins.

结局指标

主要结局

1.Plantar flexor strength: maximum voluntary contraction.

时间窗: 0-week | 4-week

2.Quality of life: SF36 questionnaire will be used to assess Quality of life, it contains 36 items. It measures health on nine multi item dimension, based on functional, status, well-being and over all evaluation of health. The higher the score at SF36, the more positive a subject was about experienced quality of life.

时间窗: 0-week | 4-week

3.Mini balance evaluation system test: It is a 14 item test with 0-2 score and total score is 28.

时间窗: 0-week | 4-week

次要结局

  • NA(NA)

研究者

发起方
Vaishali Ingole
申办方类型
Other [Principal Investigator Initiated]

研究点 (1)

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