Group Exercise Program Supported by Audiovisual Media During Hemodialysis

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Failure; Hemodialysis; Sarcopenia; Functional Capacity; Muscle Strength Dynamometer; Physical Activity Level

• Registration Number: NCT06660160
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility and Safety Assessment	From start to finish of intervention (4 weeks)	Adverse events of the exercise during the study (number of adverse events)

Secondary Outcome Measures

Name	Time	Method
Sarcopenia Risk Assessment	It will be applied before and after the 4 weeks of intervention.	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.
Muscle Strength Assessment	It will be applied before and after the 4 weeks of intervention.	Lower limb muscle strength assessments via digital manual dynamometry will be performed during HD using the MMT Lafayette Instrument Company hand dynamometer.
Muscle Characteristics	It will be applied before and after the 4 weeks of intervention.	Body composition and appendicular skeletal muscle mass will also be measured by multi-frequency bioelectrical impedance analysis (BIA),
Physical Activity Level Assessment	It will be applied before and after the 4 weeks of intervention.	The level of physical activity will be evaluated using the HAP questionnaire (Average Activity Score AAS).

Trial Locations

Locations (1)

B. Braun Avitum - Centro de Atención Renal; 🇪🇸 Massamagrell, Valencia, Spain