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临床试验/CTRI/2024/06/069597
CTRI/2024/06/069597尚未招募不适用

A study to assess the effectiveness of exercise (30 min walk) on Health-Related Quality of Life (HRQoL) among Myasthenia Gravis patients attending Neuro OPD at AIIMS, New Delhi

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月8日最近更新:

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
To access the effectiveness of exercise(30 min walk) on health-related quality of life (HRQoL) of MG patients.

研究概览

简要总结

NEED FOR STUDY It has been suggested that clinically stable MG patients, just like healthy individuals, should be able to reap the benefits of physical exercise.A regime of moderate exercise for 30 min a week has a positive impact on ADLs of MG patients. It has been seen in many studies that exercise programs have widely shown improvement in muscular and physical function. But, effectiveness of exercise programs in improvement of health related quality of life (HRQoL) had not been established so far. As far as researcher’s knowledge goes few studies have been done but it is widely scattered and generalization cannot be made so, it is done to strengthen the literature.

AIM OF THE STUDY To evaluate whether a exercise (30 min walk) could improve health-related quality of life (HRQoL) of MG patients.

PRIMARY OBJECTIVES

To access the effectiveness of exercise(30 min walk) on health-related quality of life (HRQoL) of MG patients. SECONDARY OBJECTIVES 1.     To find out the effect of exercise (30 min walk) on activities of daily living of MG patient.

2.     To find out the association between MG-QoL and selected demographic variables

METHODOLOGY Research approach– Quantitative approach

Research design- Randomised Control Trial

Independent variable

Exercise (30 min walk)

Dependent variables

•        HRQoL

•        MGADLs

Setting of the study– Neuro OPD, AIIMS, New Delhi

Population-- patients with generalized and stable Myasthenia Gravis

Sample Size- Myasthenia Gravis patients attending Neuro OPD at AIIMS, New Delhi.

Sampling Technique- Purposive Sampling technique with random allocation.

Inclusion criteria •        Myasthenia Gravis patients attending Neurology OPD at AIIMS, New Delhi.•        MG patients who are willing to participate in the study.•        MG patients who are able to follow commands and instructions.•        MG patients with MG (MGFA class 2 and 3 ) and able to undergo 6 min walk test(6MWT).•        MG patients who have the access of smart phone or smart watches.MGFA: Myasthenia gravis foundation of America Classification

•        Class II- Mild weakness affecting other than ocular muscles

  • IIa) Predominantly affecting limb or axial muscles or both
  • IIb) Predominantly affecting oropharyngeal or respiratory muscles or both

•        Class III- Moderate weakness affecting other than ocular muscles

  • lla)  Predominantly affecting limb or axial muscles or both
  • llb) Predominantly affecting oropharyngeal or respiratory muscles or both

Exclusion criteria •        MG patients who are walking for more than 150 min per week.

•        Any contraindication to exercise.

•        MG patient with other co-morbid conditions.

•        Physically disabled MG patients.

•        MG patients who are not able to communicate in Hindi or English.

 Data collection tool and techniquesTool 1: Socio-demographic variable performa (Subject data sheet including Clinical profile)

Tool 2: MGQoL-15:15-item MG-specific quality of life scale.

Tool 3: MG Activities of Daily Living (MGADL) score.

PILOT STUDY

•        Pilot study will be done in June 2024 to check the feasibility of the study.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
12.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1 Myasthenia Gravis patients attending Neurology OPD at AIIMS, New Delhi.
  • 2 MG patients who are willing to participate in the study.
  • 3 MG patients who are able to follow commands and instructions.
  • 4 MG patients with MG (MGFA class 2 and 3 ) and able to undergo 6 min walk test(6MWT).
  • 5 MG patients who have the access of smart phone or smart watches.

排除标准

  • 1 MG patients who are walking for more than 150 min per week.
  • 2 Any contraindication to exercise.
  • 3 MG patient with other co-morbid conditions.
  • 4 Physically disabled MG patients.
  • 5 MG patients who are not able to communicate in Hindi or English.

结局指标

主要结局

To access the effectiveness of exercise(30 min walk) on health-related quality of life (HRQoL) of MG patients.

时间窗: before and after 4 weeks of intervention or standard care provided to the patients

次要结局

  • To find out the effect of exercise (30 min walk) on activities of daily living of MG patient.(To find out the association between MG-QoL & selected demographic variables)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Neha Sah

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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