Clinical trial NCT06660160: Group Exercise Program Supported by Audiovisual Media During Hemodialysis
Official title: Evaluating the Feasibility and Safety of a Group Exercise Program Supported by Audiovisual Media During Hemodialysis (GrExID)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Failure
Hemodialysis
Sarcopenia
Functional Capacity
Muscle Strength Dynamometer
Physical Activity Level
Keywords: Chronic Kidney Failure
Hemodialysis
Exercise
Sarcopenia
Muscle strength
Functional capacity
Dynamometer
Physical activity level
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: B.Braun Avitum AG
name: Universidade Federal de Juiz de Fora
First posted: 2024-10-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old of both sexes;
* Undergoing HD for at least three months in three sessions per week, four hours, totaling 12 hours per week.

Exclusion Criteria:

* Lower limb amputations;
* Neurological, musculoskeletal, or osteoarticular disorders;
* Severe and unstable comorbidities;
* Undergoing high doses of corticosteroids (\>30 mg/day);
* Inability to understand the measurement methods used.

Primary outcomes:
measure: Feasibility and Safety Assessment
timeFrame: From start to finish of intervention (4 weeks)
measure: Feasibility and Safety Assessment
timeFrame: From start to finish of intervention (4 weeks)
Secondary outcomes:
measure: Sarcopenia Risk Assessment
timeFrame: It will be applied before and after the 4 weeks of intervention.
measure: Muscle Strength Assessment
timeFrame: It will be applied before and after the 4 weeks of intervention
measure: Muscle Strength Assessment
timeFrame: It will be applied before and after the 4 weeks of intervention.
measure: Muscle Characteristics
timeFrame: It will be applied before and after the 4 weeks of intervention
measure: Muscle Characteristics
timeFrame: It will be applied before and after the 4 weeks of intervention.
measure: Physical Activity Level Assessment
timeFrame: It will be applied before and after the 4 weeks of intervention.
Other outcomes:
Locations:
city: Massamagrell
country: Spain
facility: B. Braun Avitum - Centro de Atención Renal
state: Valencia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.