Chronic Kidney FailureGrExIDNCT06660160
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
A study testing Exercise program supported by audiovisual media in people with Chronic Kidney Failure and Hemodialysis, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure, Hemodialysis, Sarcopenia
- What is being tested?
- Exercise program supported by audiovisual media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
B. Braun Avitum - Centro de Atención Renal
Massamagrell, Valencia, 46130
About this study
Official title: 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.
Read the 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
- Being tested
- Exercise program supported by audiovisual media
- Keywords
- Chronic Kidney Failure, Hemodialysis, Exercise, Sarcopenia, Muscle strength, Functional capacity, Dynamometer, Physical activity level
- Medical subject headings
- Kidney Failure, Chronic, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program supported by audiovisual mediaOther
Also called Exercise, Exercise training, Exercise training during hemodialysis, Physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Safety Assessment
Feasibility will be assessed through adherence rate (number of sessiones performed out of sessions offered).
Measured: From start to finish of intervention (4 weeks)
Feasibility and Safety Assessment
Adverse events of the exercise during the study (number of adverse events)
Measured: From start to finish of intervention (4 weeks)
Secondary outcomes (6)
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.
Measured: It will be applied before and after the 4 weeks of intervention.
Muscle Strength Assessment
Handgrip strength
Measured: 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.
Measured: 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.
Measured: 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),
Measured: 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).
Measured: It will be applied before and after the 4 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start28 Oct 2024
- Primary completion29 May 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- B.Braun Avitum AG, Universidade Federal de Juiz de Fora
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660160
- Sponsor's protocol ID
- GrExID
- Acronym
- GrExID
- Status last verified
- Jan 2026
- First submitted
- 18 Oct 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30916415Reboredo 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.
PubMed 22133251Sharma 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.
PubMed 25392147
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Feasibility And Safety Of A Group Exercise Program Supported By Audiovisual Media During Hemodialysis (GrExID)
- ClinicalTrials.gov ID
- NCT06660160
- Acronym / sponsor ID
- GrExID / GrExID
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- B.Braun Avitum AG, Universidade Federal de Juiz de Fora
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Other: Exercise program supported by audiovisual mediaPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program supported by audiovisual mediaAlso: Exercise, Exercise training, Exercise training during hemodialysis, PhysiotherapyThe 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 | Intervention Group (IG) |
Primary outcome
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).
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)
6 secondary outcomes
Sarcopenia Risk Assessment
Time frame: It will be applied before and after the 4 weeks of intervention.
Muscle Strength Assessment
Time frame: It will be applied before and after the 4 weeks of intervention
Muscle Strength Assessment
Time frame: It will be applied before and after the 4 weeks of intervention.
Muscle Characteristics
Time frame: It will be applied before and after the 4 weeks of intervention
Muscle Characteristics
Time frame: It will be applied before and after the 4 weeks of intervention.
Physical Activity Level Assessment
Time frame: It will be applied before and after the 4 weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 30916415Segura-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.
- Background: PubMed 22133251Reboredo 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.
- Background: PubMed 25392147Sharma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program supported by audiovisual media in people with Chronic Kidney Failure and Hemodialysis, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Safety Assessment (time frame: From start to finish of intervention (4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.