Group Exercise Program Supported By Audiovisual Media During Hemodialysis

NCT ID: NCT06660160

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2026-05-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise program supported by audiovisual media

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Exercise; Exercise training; Exercise training during hemodialysis; Physiotherapy; Online exercise training

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B.Braun Avitum AG

INDUSTRY

Sponsor Role: collaborator

Universidade Federal de Juiz de Fora

UNKNOWN

Sponsor Role: collaborator

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Eva Segura Ortí

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

B. Braun Avitum - Centro de Atención Renal

Massamagrell, Valencia, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 30916415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22133251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25392147 (View on PubMed)

Other Identifiers

GrExID

Identifier Type: -

Identifier Source: org_study_id