Comparative Study Between Two Different Renal Rehabilitation Protocols on Respiratory and Peripheral Muscles Strength in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 6minute walk test
研究概览
简要总结
This clinical trial will investigate how two different intradialytic exercise programs affect health in older adults with chronic kidney disease receiving regular hemodialysis. One group will perform aerobic exercise (cycling) combined with inspiratory muscle training, another group will perform resistance (strength) exercises combined with inspiratory muscle training, and a third control group will receive standard medical care without structured exercise. Men and women over 60 years of age on regular hemodialysis will be recruited from the kidney dialysis department and will exercise three times per week for three months.
详细描述
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Type of study: Randomized controlled trial
This study is a prospective interventional randomized controlled trial that will be conducted on ninety chronic kidney disease (CKD) patients on regular hemodialysis of both sexes aged over sixty years. They will be recruited from the kidney dialysis department and randomly divided into three equal groups:
Intervention group 1: Includes 30 CKD patients on hemodialysis who will receive aerobic exercise, inspiratory muscle training and medical treatment.
Intervention group 2: Includes 30 CKD patients on hemodialysis who will receive resistance exercise, inspiratory muscle training and medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 60 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both gender
- •With chronic kidney disease
- •Unemployed living a sedentary lifestyle
- •Receive regular hemodialysis sessions at 3months ago
- •All of them have vascular access through arteriovenous fistula
- •Age range over 60years
- •Fully understand purpose and procedure of study
- •Stable and have sufficient level of cognition and ability to understand instructions
排除标准
- •• Real difficulties with understanding and signing The written informed consent
- •Recent sequela of cerebrovascular accidents
- •Osteoarticular or musculoskeletal diseases
- •Un controlled systemic hypertension
- •Un controlled diabetes
- •Un stable angina
- •Infectious disease
- •Acute respiratory failure
- •Recent acute myocardial infarction
- •Peripheral vascular alterations
研究组 & 干预措施
Aerobic exercise plus inspiratory muscle training (group A)
I)inspiratory muscle training:
Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week
Aerobic exercise:
5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR reserve) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week .
干预措施: aerobic exercise (Device)
Aerobic exercise plus inspiratory muscle training (group A)
I)inspiratory muscle training:
Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week
Aerobic exercise:
5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR reserve) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week .
干预措施: standard medical treatment (Other)
Aerobic exercise plus inspiratory muscle training (group A)
I)inspiratory muscle training:
Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week
Aerobic exercise:
5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR reserve) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week .
干预措施: inspiratory muscle training (Device)
Resistance exercise plus inspiratory muscle training (group B)
Resistance exercise:
Dynamic closed- and open-chain resistance exercises performed by the patients quadriceps and hamstrings muscles . Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form.
inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.
干预措施: resistance exercise (Device)
Resistance exercise plus inspiratory muscle training (group B)
Resistance exercise:
Dynamic closed- and open-chain resistance exercises performed by the patients quadriceps and hamstrings muscles . Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form.
inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.
干预措施: standard medical treatment (Other)
Resistance exercise plus inspiratory muscle training (group B)
Resistance exercise:
Dynamic closed- and open-chain resistance exercises performed by the patients quadriceps and hamstrings muscles . Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form.
inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.
干预措施: inspiratory muscle training (Device)
group C (control group)
in this group there is no exercise ,patients have assessment pre and post 3 months and follow up
干预措施: standard medical treatment (Other)
结局指标
主要结局
6minute walk test
时间窗: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
-6 minute walk test : to detect functional capacity , carry out in a 30 meters line along the passage way , the tape is placed every 2 meter . patients are instructed to walk the longest possible distance in 6 minutes continuously and turning around at the final mark without stopping .they are instructed to walk as far as they can for 6 minutes without running or jogging .covered distance in meters is measured at the end of analysis.
Maximum inspiratory pressure
时间窗: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
-Maximum inspiratory pressure : to determine the inspiratory muscle strength before and after training. the patient will be instructed to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the 'bite blocks' are between the teeth. The subject should then exhale to RV (Residual Volume), then perform a forced inhalation against the mouthpiece with as much effort as possible for as long as possible (minimum 2 seconds). while the participants were seated in a reclining chair (with knees and hips at 90) in a HD room at the beginning of the HD session .
次要结局
- Kidney Disease & Quality of Life (KDQOL-SF36)(Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention))
- peak vo2(Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention))
- modified Borg scale(Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention))
- creatinine(Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention))
- GFR(Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention))
- KT/V(Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention))
研究者
Marwa Atta Ahmed
physiotherapist
Beni-Suef University