跳至主要内容
临床试验/CTRI/2025/04/083931
CTRI/2025/04/083931尚未招募不适用

Effectiveness of Structured Exercise Program along with Jacobson’s Relaxation on Fitness Outcomes and Quality of Life in HIV Children: Randomized Control Trial

Maharashtra Institute of Physiotherapy, Latur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月4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
60
试验地点
1
主要终点
1. VO2 max

研究概览

简要总结

The study will be initiated after getting clearance from the Institutional Ethical Committee. • The Participants will be selected based on the inclusion and exclusion criteria and informed consent will be taken from the participants and the caretaker. • 60 HIV children will be considered and they will be randomly allocated into two groups i.e. Experimental group and Control group. The preintervention values will be calculated in the groups using outcome measures. • The physician’s consent will be obtained for the subject’s participation. • Exercise testing will be done three times: at the beginning, at the 4th week and the end of the 8th week.

• Group A (Experimental group)

– The experimental group will be given Aerobic Training and resistance training with Jacobson’s relaxation Intervention – Each session will be of 60-80 mins -3 sessions/week for 8 weeks. (2 months)

• Exercise Protocol:

  1. Warm-up and stretching exercises – 10 mins.  (Active mobility exercises, Stretching exercises.)

2. Aerobic Training (Circuit Interval Program): Type of exercise: - Spot marching 3min - spot jumping – 3 mins - static cycling – 3 mins - Step-up and step-down exercises – 3 mins. There will be a 2-minute (passive interval) break between the exercises. Intensity: Low to Moderate. Frequency: 3 sessions/week.

3. Strength training: The participants will have to use dumbells, therabands, and weight cuffs of 50% of 1 RM to strengthen the major group of muscles. The strength training will be carried out for 20 minutes, with 10 reps for each major group of muscle, and a rest period of 1-2 minutes in between. 4. Cool Down Exercises – (10 mins) - Active Mobility Exercises. - Upper Body stretch (Shoulder stretch, Tricep stretch) - Lower Body Stretch.

Jacobson’s relaxation technique – (20 minutes) Give the following instructions to the Participants. • Gently breathe in, hold, and let go. • Gently pull your toes up towards your knees – just a little – hold briefly – and let go. Recognize the difference. • Press your heels into the floor – hold – and let go. • Pull your knees together – hold briefly – and now let them drift apart a little. Be aware of the new position. • Squeeze your buttocks together – hold – now let go. • Gently pull in your tummy muscles towards your spine – hold briefly – now let go. Feel the difference. • Shoulders – gently pull them up towards your ears, just enough to recognize the tension – hold briefly – now let go. Recognize the new position. • Gently press your elbows and upper arms to the sides of your body – hold for a moment – now let go. • Hands – gently clench – hold – and let go. • Push your head forward slightly, hold briefly, now let your head go back to a balanced position. Feel the difference. • Grit your teeth together – hold briefly – now let your jaw sag slightly. Feel the difference. • Lips – press together – now let go until hardly touching. Purse your lips – now let go and feel the difference. • Press your tongue briefly to the roof of your mouth – hold – and let it drop loosely. Feel the new position. • Eyes – screw them up a little – hold – and let go. • Forehead – frown a little – hold – now let go.

•Group B (Control group):

Jacobson’s relaxation technique -

Only Relaxation Technique will be given to Control Group.

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
6.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • •Children diagnosed case of HIV.
  • •Both male and female.
  • •Children who can complete 6MWT.
  • •Physician consent.
  • •Stage 1 of HIV infection.

排除标准

  • •Critically ill Children.
  • •Children with musculoskeletal and neurological conditions.
  • •Children who have undergone recent surgeries.
  • •Psychologically unstable Children.

结局指标

主要结局

1. VO2 max

时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks

2. 1 RM strength testing

时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks

3. Peds Quality of Life Inventory.

时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks

4. Body Mass Index

时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks

次要结局

  • 6 Minute Walk Test(Participants should be able to complete 6MWT)

研究者

发起方
Maharashtra Institute of Physiotherapy, Latur
申办方类型
Research institution and hospital

研究点 (1)

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