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Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness
Application of PlazePod Device and Electrical Stimulation and comparison between them to decrease fall Risk in Hemodialysis Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BlazePod Training plus Lifestyle Education | Experimental | Participants in this arm will receive an interactive sensorimotor training program using the BlazePod system combined with a structured lifestyle education program. BlazePod training will focus on improving balance, reaction time, coordination, and functional mobility through static and dynamic balance tasks, reactive stepping, and lower-limb coordination exercises. Training sessions will be conducted three times per week for 30 minutes over a period of 12 weeks under the supervision of a physical therapist. In addition, participants will attend a weekly lifestyle education session addressing renal nutrition, fluid management, safe physical activity, fall prevention strategies, sleep hygiene, fatigue management, and medication adherence. |
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| Tens plus Lifestyle Education | Active Comparator | Participants in this arm will receive neuromuscular electrical stimulation (NMES) applied to the lower limb muscles, including bilateral quadriceps and hamstrings, combined with the same structured lifestyle education program as the experimental group. NMES will be delivered using a portable electrical stimulation device with parameters adjusted to produce visible and comfortable muscle contractions. Sessions will be conducted three times per week for 30 minutes over 12 weeks under physical therapist supervision. Lifestyle education sessions will be provided once weekly and will include renal nutrition, fluid control, safe physical activity, fall prevention strategies, sleep hygiene, fatigue management, and medication adherence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device + Behavioral | Device | This intervention consists of interactive sensorimotor training using the BlazePod system, a visual stimulus-based device designed to improve balance, coordination, reaction time, and functional mobility. Participants will perform static and dynamic balance exercises, reactive stepping drills, lower-limb coordination tasks, and dual-task activities in response to visual cues emitted by the BlazePod sensors. Training sessions will be conducted three times per week, with each session lasting 30 minutes, over a total duration of 12 weeks. All sessions will be supervised by a licensed physical therapist to ensure safety and appropriate progression of exercise difficulty. The intervention aims to reduce fall risk by enhancing neuromuscular control and postural stability in hemodialysis patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Falling Assessed by Timed Up and Go Test (TUG) | Change in risk of falling measured using the Timed Up and Go (TUG) test, recorded in seconds. Lower scores indicate better functional mobility and reduced fall risk. | Baseline and after 12 weeks of intervention |
| Balance Performance Assessed by Berg Balance Scale (BBS) | Change in static and dynamic balance measured using the Berg Balance Scale (BBS), scored from 0 to 56 points, with higher scores indicating better balance performance. | Baseline and after 12 weeks |
| Lower Limb Muscle Strength | Change in lower limb muscle strength measured using a hand-held dynamometer, recorded in kilograms (kg). | Baseline and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Level | Change in physical activity level measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), expressed in MET-minutes/week. | Baseline and after 12 weeks |
| Kidney Disease-Related Quality of Life |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Intervention Program | Participant adherence to the prescribed physical intervention and lifestyle education sessions, expressed as percentage of attended sessions. | Throughout the 12-week intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samia Wagdy El said Diab, PHD | Contact | 01094762028 | 01094762028 | Samiaahmeddiab@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta | Tanta | Alquarbia | 31111 | Egypt |
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| Label | URL |
|---|---|
| This website provides scientific articles and studies related to lifestyle interventions, physical exercise, and fall risk in hemodialysis patients. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LifestyleStudy2026 | Study Protocol | View IPD |
"At this time, we have not decided whether individual participant data will be shared. This is due to considerations of patient privacy, confidentiality, and ongoing analysis. A decision regarding data sharing will be made after study completion and in accordance with ethical guidelines."
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Application two Devices of PlazePod Device and Electrical Stimulation for 60 patients each group 30 for 3months for 40-50age Additionally life style education program, such as: Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness For 3 months, there was one session every week, lasting 30 minutes and comparison between two groups
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Application of PlazePod Device and Electrical Stimulation for 60 patients each group 30 for 3months for 40-50age Additionally life style education program, such as: Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness For 3 months, there was one session every week, lasting 30 minutes
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| Neuromuscular Electrical Stimulation (NMES) | Device | This intervention involves the application of neuromuscular electrical stimulation to the lower limb muscles, specifically the bilateral quadriceps and hamstrings, using a portable electrical stimulation device. Surface electrodes will be placed over the motor points to elicit visible and comfortable muscle contractions. Stimulation parameters will include a frequency of 35-50 Hz, pulse width of 200-400 microseconds, and a duty cycle of 10 seconds on and 30 seconds off. Sessions will be administered three times per week for 30 minutes over 12 weeks under the supervision of a physical therapist. The intervention aims to improve muscle strength, balance, functional mobility, and reduce fall risk in hemodialysis patients. |
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Change in quality of life measured using the Kidney Disease Quality of Life Short Form questionnaire (KDQOL-36), reported as total score.
| Baseline and after 12 weeks |
Study protocol available for review. Additional data can be shared upon request following ethical approval. |