Group Exercise Program Supported By Audiovisual Media During Hemodialysis (GrExID)

Evaluating The Feasibility And Safety Of A Group Exercise Program Supported By Audiovisual Media During Hemodialysis (GrExID)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemodialysis; Sarcopenia; Functional Capacity; Chronic Kidney Failure; Muscle Strength Dynamometer; Physical Activity Level
• Intervention / Treatment: Other: Exercise program supported by audiovisual media

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Massamagrell, Valencia, Spain, 46130
      • B. Braun Avitum - Centro de Atención Renal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Exercise program supported by audiovisual media; 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.; The first level of difficulty includes 5 exercises for the lower limbs and 3 exercises for the upper limbs. One set of 10 repetitions will be performed for each exercise per session.; The second level includes 3 exercises for the lower limbs and 2 exercises for the upper limbs. These consist of proprioceptive neuromuscular facilitation diagonals for both the lower and upper limbs. One set of 10 repetitions will be performed for each exercise, once per week, for 3 weeks.; The third level includes 8 combined lower and upper limb exercises performed simultaneously. One set of 20 repetitions will be performed for each exercise. Exercises will be performed 3 times per week over a 4-week period, for a total of 12 planned exercise sessions.; Other Names: Exercise; Physiotherapy; Exercise training; Exercise training during hemodialysis; Online exercise training
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Collaborators: B.Braun Avitum AG; Universidade Federal de Juiz de Fora

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Dynamometer; Sarcopenia; Hemodialysis; Muscle strength; Physical activity level; Functional capacity; Chronic Kidney Failure
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Kidney Failure, Chronic; Sarcopenia; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation; Exercise; Physical Therapy Modalities
• Other Study ID Numbers: GrExID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No