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临床试验/CTRI/2026/02/102809
CTRI/2026/02/102809尚未招募不适用

Effect Of Concurrent Exercise Training Along With 4 Square Breathing On Cardiopulmonary Parameters, CD4 Cell Count And QOL In HIV-I Seropositive Individuals.A Randomised Clinical Trial.

Maharashtra Institute of Physiotherapy, Latur1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年2月10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
56
试验地点
1

研究概览

简要总结

The study is initiated after getting clearance from the Institutional Ethical Committee. Participants will be selected based on inclusion and exclusion criteria and informed consent will be taken from the participants and the caretaker. 56 HIV individuals will be considered and they will be randomly allocated by cheat method  into two groups. Group A is experimental group including 28 participants who will receive concurrent exercise training which is a combination of aerobic exercise and resistance training along with 4-square breathing and Group B including 28 participants will receive 4 square breathing with the standard care.

The intervention will be given for 16 weeks. Before starting the pre assessment of participants will be done and post assessment will be done at the end of 16th week.

Group A: Experimental group

The exercise protocol:

1.Warm Up exercise :– 5-10 mins. (Active mobility exercises, Light jogging and Flexibility movements, Stretching exercises.)

  1. Aerobic Training :- 30mins Type of exercise:

Static Cycling – 20 mins(40-45% of HRmax),

Brisk walking – 3 mins,

Step up and Step down exercises – 3 mins.

There will be 2 mins break between the exercises.

Intensity: Low to Moderate.

Frequency : 3 sessions/week.

  1. Strength training : The participants will have to use therabands of 50% of 1 RM to strengthen the major group of muscles (work load increased by 5% each two weeks).

The strength training will be carried out for 20- 30 mins with 3 sets ,10 reps for each major group of muscle with rest period of 1-2 mins in between.

  1. Cool Down Exercises:- (5-10 mins) : Stretching and breathing exercises

  2. 4 Square Breathing Exercise:- (4 mins) : 4 square breathing involve four basic steps, each lasting 4 seconds:

  3. Breathing in

  4. Holding the breath

  5. Breathing out

  6. Holding the breath

Group B Control group:

4 Square Breathing Exercise:- (4 mins) :

4 square breathing involve four basic steps, each lasting 4 seconds:

  1. Breathing in

  2. Holding the breath

  3. Breathing out

  4. Holding the breath

Outcome Measures:

• Cardiopulmonary parameters: Respiratory Rate(HR), Blood pressure(BP), oxygen saturation( SpO2)

• CD4 cell count :- measured pre-intervention & post intervention (via blood test).{Sensitivity=67%, specificity=96%}

• QOL assessed using SF-36 questionnaire(r=0.86)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
10.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Diagnosed with HIV-I seropositive 2.Age group 10-35 years 3.Both male and female Stage 1 of HIV infection 4.Immunosuppression:CD4 Cell Count less than or equal to 400 cells/microlitre 5.Physician consent: participants who are able to perform exercise 6.Who are able to complete 6MWT.

排除标准

  • 1.Critically ill 2.With MSK Conditions(fractures, severe osteoporosis)and Neurological Conditions 3.Who have undergone recent surgeries.
  • 4.Who are psychologically unstable.
  • 5.Severe anaemia 6.Uncontrolled co-morbidities like diabetes,hypertension,heart diseases and chronic lung disease.
  • 7.Recent hospitalization for any major illness.

研究者

发起方
Maharashtra Institute of Physiotherapy, Latur
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rachana Murkute

Maharashtra Institute of Physiotherapy, Latur

研究点 (1)

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