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NCT Number: NCT06660160

Group Exercise Program Supported By Audiovisual Media During Hemodialysis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Kidney Failure Atrophy Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Functional Capacity Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Motor Activity Muscle Strength Dynamometer Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Activity Level Renal Insufficiency Renal Insufficiency, Chronic Sarcopenia Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

B. Braun Avitum - Centro de Atención Renal

Massamagrell, Valencia, 46130, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Exercise, Exercise training, Exercise training during hemodialysis, Physiotherapy, Online exercise training

Primary outcomes

  1. 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).

  2. Feasibility and Safety Assessment

    Time frame: From start to finish of intervention (4 weeks)

    Adverse events of the exercise during the study (number of adverse events)

Secondary outcomes

  1. Sarcopenia Risk Assessment

    Time frame: 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.

  2. Muscle Strength Assessment

    Time frame: It will be applied before and after the 4 weeks of intervention

    Handgrip strength

  3. Muscle Strength Assessment

    Time frame: 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.

  4. Muscle Characteristics

    Time frame: It will be applied before and after the 4 weeks of intervention

    The quantity and quality of muscle mass will be evaluated by the cross-sectional area of the rectus femoris muscle, measured by muscle ultrasound.

  5. Muscle Characteristics

    Time frame: 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),

  6. Physical Activity Level Assessment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Collaborators

  • B.Braun Avitum AG
  • Universidade Federal de Juiz de Fora

Registry information

Official study title

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

Acronym: GrExID

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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