Evaluating The Feasibility And Safety Of A Group Exercise Program Supported By Audiovisual Media During Hemodialysis (GrExID)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Feasibility and Safety Assessment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention Group (IG)
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.
Intervention: Exercise program supported by audiovisual media (Other)
Control Group (CG)
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.
Outcomes
Primary Outcomes
Feasibility and Safety Assessment
Time Frame: From start to finish of intervention (4 weeks)
Feasibility will be assessed through adherence rate (number of sessiones performed out of sessions offered).
Secondary Outcomes
- Sarcopenia Risk Assessment(It will be applied before and after the 4 weeks of intervention.)
- Muscle Strength Assessment(It will be applied before and after the 4 weeks of intervention.)
- Muscle Characteristics(It will be applied before and after the 4 weeks of intervention.)
- Physical Activity Level Assessment(It will be applied before and after the 4 weeks of intervention.)
- Muscle Strength Assessment(It will be applied before and after the 4 weeks of intervention)
- Muscle Characteristics(It will be applied before and after the 4 weeks of intervention)
Investigators
Eva Segura Ortí
Principal Investigator
Cardenal Herrera University