Group Exercise Program Supported By Audiovisual Media During Hemodialysis

NCT06660160 | Active Not Recruiting

• 1 other identifier: GrExID
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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 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

• Muscle Characteristics

  It will be applied before and after the 4 weeks of intervention.

Study Arms (2)

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.

Other: Exercise program supported by audiovisual media

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.

Interventions

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. * 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.

Also known as: Exercise, Exercise training, Exercise training during hemodialysis, Physiotherapy, Online exercise training

Intervention Group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead
• B.Braun Avitum AG: collaborator
• Universidade Federal de Juiz de Fora: collaborator

Study Sites (1)

B. Braun Avitum - Centro de Atención Renal

Massamagrell, Valencia, 46130, Spain

Location

Related Publications (3)

• 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.

  PMID: 30916415 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.

  PMID: 22133251 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.

  PMID: 25392147 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Sarcopenia; Motor Activity

Interventions

Exercise; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 28, 2024
• Study Start: October 28, 2024
• Primary Completion: May 29, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)