Effectiveness Of Low to Moderate Intensity Aerobic Exercises Along with Inspiratory Muscle Training on Physical Performance, Kinesiophobia and Quality of Life in CKD Patients With Frailty- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)Tempa scale for kinesiophobia
研究概览
简要总结
Informed consent will be obtained, and participants (50 individuals aged 18-60) will be selected based on inclusion/exclusion criteria. They will be randomly assigned into two groups: Group A (Intervention) - aerobic exercises with inspiratory muscle training (IMT), and Group B (Control) - aerobic exercises only. Assessments will include physical performance (VO2), kinesiophobia (Tempa scale), and quality of life (KDQOL-36). The exercise protocol will be conducted 3 days per week for 12 weeks, with each session including 5-10 minutes of warm-up, 20-60 minutes of aerobic conditioning, and 5-10 minutes of cool-down. Pre, mid, and post-intervention evaluations will be done for all participants
GROUP A: The Aerobic exercise
Warm up exercises (5-10 min): Stretching of large muscle groups like calf ,hamstrings, quadriceps ,triceps ,biceps, pectoralis major.
Conditioning programme (20-60 min) :static cycling, stepping activity, walking (3min each) [2 min of passive interval after each session]
Cool down exercise (5-10 min):Stretching combined with Active range of motion exercises of all the peripheral joints.
Exercise prescription will be individualized, with an initial intensity of 40%- 60% of MHR or/and RPE: 11- 13
Exercise duration will be increased by 5 min after every 2 weeks (to maximum of 60 mins)
**Inspiratory muscle training:**5 series with 10 reps each series 2 min interval overload adjust weekly; Beginning with 50% of MIP for 1st to 3rd week ,60% of MIP for 4th to 6th week,70% of MIP for 7th to 9th week, 80% of MIP for 10th to 12th week.
GROUP B: The Aerobic exercise
Warm up exercises (5-10 min): Stretching of large muscle groups like calf ,hamstrings, quadriceps ,triceps ,biceps, pectoralis major.
Conditioning programme (20-60 min) :static cycling, stepping activity, walking (3min each) [2 min of passive interval after each session]
Cool down exercise (5-10 min):Stretching combined with Active range of motion exercises of all the peripheral joints.
Exercise prescription will be individualized, with an initial intensity of 40%- 60% of MHR or/and RPE: 11- 13
Exercise duration will be increased by 5 min after every 2 weeks (to maximum of 60 mins)
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •If the score of frailty phenotype criteria is more than or equal to 3 patient consider as a frail 2)Patients should able complete 6 min walk test 3)Resting SPO2 more than or equal to 90 percent 4)Chronicity of the disease (more than 3 months).
排除标准
- •Uncontrolled DM 2)BP more than 180/110 mmhg or less than 80/60mmhg 3)Muscle pain and cramp 4)RPE greater than or equal to 15 5)Chest pain 6)Arrhythmias 7)Obstructive lung disease 8)History of thoracic and abdominal surgery in past 6 month 9)Osteoarthritis of knee.
结局指标
主要结局
1)Tempa scale for kinesiophobia
时间窗: All outcomes will assess at baseline, at 6th week and 12th week
2)VO2 max
时间窗: All outcomes will assess at baseline, at 6th week and 12th week
3)KDQOL-36
时间窗: All outcomes will assess at baseline, at 6th week and 12th week
次要结局
- 1)6MWT(2)(J-CHS) criteria for frailty)
研究者
Dr Gauri Mahendra Sorty
Maharashtra Institute Physiotherapy , Latur