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| Name | Class |
|---|---|
| B.Braun Avitum AG | INDUSTRY |
| Universidade Federal de Juiz de Fora | UNKNOWN |
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People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Exercise programs during HD are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. Therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during HD sessions. Additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.
A 4-week randomized experimental study will be conducted, using an exercise protocol during HD, broadcast simultaneously on television. The frequency of exercise completion, reasons for non-completion, adverse events, as well as sarcopenia, muscle strength, muscle characteristics through ultrasound and electrical bioimpedance, and physical activity levels will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (IG) | Experimental | Patients over 18 years old of both sexes, who have been undergoing HD for at least three months, generally in three sessions per week that are in the room that was randomized to do exercise. |
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| Control Group (CG) | No Intervention | Patients over 18 years old of both sexes, who have been undergoing HD for at least three months, generally in three sessions per week that are in the room that was randomized to will continue with the usual treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program supported by audiovisual media | Other | The intervention group will perform the group exercise protocol during HD sessions. The videos with the exercises will be broadcast on all televisions simultaneously, so that the volunteers perform the exercises along with the person in the video.
Exercises will be performed 3 times per week over a 4-week period, for a total of 12 planned exercise sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Safety Assessment | Feasibility will be assessed through adherence rate (number of sessiones performed out of sessions offered). | From start to finish of intervention (4 weeks) |
| Feasibility and Safety Assessment | Adverse events of the exercise during the study (number of adverse events) | From start to finish of intervention (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenia Risk Assessment | The risk of sarcopenia will be evaluated using the SARC-F (Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls )questionnaire. Score ranges from 0 a 10, higher scores mean higher risc of sarcopenia. | It will be applied before and after the 4 weeks of intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| B. Braun Avitum - Centro de Atención Renal | Massamagrell | Valencia | 46130 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30916415 | Background | Segura-Orti E, Garcia-Testal A. Intradialytic virtual reality exercise: Increasing physical activity through technology. Semin Dial. 2019 Jul;32(4):331-335. doi: 10.1111/sdi.12788. Epub 2019 Mar 27. | |
| 22133251 | Background | Reboredo MM, Neder JA, Pinheiro BV, Henrique DM, Faria RS, Paula RB. Constant work-rate test to assess the effects of intradialytic aerobic training in mildly impaired patients with end-stage renal disease: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Dec;92(12):2018-24. doi: 10.1016/j.apmr.2011.07.190. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Muscle Strength Assessment |
Handgrip strength |
| It will be applied before and after the 4 weeks of intervention |
| Muscle Strength Assessment | Lower limb muscle strength assessments via digital manual dynamometry will be performed during HD using the MMT Lafayette Instrument Company hand dynamometer. | It will be applied before and after the 4 weeks of intervention. |
| Muscle Characteristics | The quantity and quality of muscle mass will be evaluated by the cross-sectional area of the rectus femoris muscle, measured by muscle ultrasound. | It will be applied before and after the 4 weeks of intervention |
| Muscle Characteristics | Body composition and appendicular skeletal muscle mass will also be measured by multi-frequency bioelectrical impedance analysis (BIA), | It will be applied before and after the 4 weeks of intervention. |
| Physical Activity Level Assessment | The level of physical activity will be evaluated using the HAP questionnaire (Average Activity Score AAS). | It will be applied before and after the 4 weeks of intervention. |
| 25392147 | Background | Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |