Chronic Kidney Disease on HemodialysisREHAD- CKDNCT07642778
Reference Values for Lower-Limb Dynamometry in Patients With Chronic Kidney Disease (REHAD-CKD)
An observational study of Chronic Kidney Disease on Hemodialysis, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Patients with chronic kidney disease (CKD) undergoing hemodialysis present musculoskeletal complications, such as sarcopenia, which impair their functionality and are associated with an increased risk of mortality. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to Dec 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD undergoing HD in DIAVERUM centers in Spain, male and female, aged 18 and older, who have been on dialysis for more than one month.
Who may be able to join
- ≥1 months on HD (3 weekly sessions of 4 hours)
Who cannot join
- Lower-limb amputation;
- Neurological, musculoskeletal or osteoarticular disorders;
- Severe/unstable comorbidities (e.g., decompensated heart failure or diabetes, unstable angina, recent MI, uncontrolled hypertension, severe lung disease, acute infection);
- <1 months on HD;
- <2 sessions/week,
- Inability to understand assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Diaverum Madrid
Madrid
Shaira Ms Martínez Vaquera, Manager, +34 683 236 547, shaira.martinez@diaverum.com
Eva Ms Segura Ortí, Professor, +34671580094, esegura@uchceu.es
About this study
Patients with chronic kidney disease (CKD) undergoing hemodialysis present musculoskeletal complications, such as sarcopenia, which impair their functionality and are associated with an increased risk of mortality. Functional assessment in this population is complex due to the organization of hemodialysis schedules and patients' dependence on medical transportation, which hinders evaluation outside the dialysis setting.
The assessment of lower limb strength is of great relevance, as an adequate level of muscle strength in this region is essential for performing many activities of daily living, including walking, sit-to-stand and stand-to-sit movements, as well as ascending and descending stairs. Our research group has published a study demonstrating the safety and reliability of intradialytic measurement of hip flexion and abduction strength; however, reference values for the dialysis population and for individuals with CKD in general are currently unknown.
The primary aim of this study is to propose reference values for hip flexor and abductor muscle strength measured using a hand-held dynamometer in individuals with chronic kidney disease (CKD). Secondary objectives include assessing the association between lower limb muscle strength measured with a hand-held dynamometer and handgrip strength, physical activity level, frailty, gait speed, performance in the 10-repetition sit-to-stand-to-sit test, ultrasound assessment of the rectus femoris muscle, and health-related quality of life.
- Conditions
- Chronic Kidney Disease on Hemodialysis
- Keywords
- Chronic Kidney Disease, Lower limb strength, Intradialytic assessment
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| REHAB-CKD group | The target population of the present study consists of patients with chronic kidney disease undergoing hemodialysis in DIAVERUM centers in Spain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference values for Lower Limb Strengh
Lower limb strengh will be evaluated using handheld dynamometer (Lafayette Manual Muscle Testing System Model-01165, Lafayette IN, USA) for hip flexors and hip abductors.Testing will follow a strict structured order: first hip flexors and then hip abductors. Within each muscle group, legs will be alternated, starting with the dominant leg and then the nondominant leg, to allow specific rest periods between muscle groups (15 seconds). Hip flexors will be assessed with the patients with both hips and knees bent. The dynamometer will be placed on the anterior part of the thigh, 2 centimetres below of patella. Hip abductors will be assessed with both legs extended at the hip and knee. The dynamometer will be placed on the lateral part of the thigh, 2 centimetres below of the knee joint line. During both measurements physiotherapist will apply force in the opposite direction of the movement. Unit of measure: Newton (N).
Measured: Baseline
Secondary outcomes (11)
Muscle strength assessment Handgrip
It will use a Jamar® Approved Hydraulic Hand Dynamometer. The participant will be seated in a chair with their back straight and the arm flexed at 90°. The test will be repeated three times for each hand (3-5 seconds), with rest periods between repetitions to avoid muscle fatigue. Unit of measure: Kilogram (Kg).
The cut-off points for loss of muscle strength will be set greater than or equal to 27 kg for men and greater than or equal to 16 kg for women, based on values defined by Mathiowetz et al. and included in the European clinical nutrition guidelines as a phenotypic criterion for disease-related malnutrition.
Measured: Baseline
Human Activity Profile
The Human Activity Profile (HAP) consist of 94 questions addressing different domains of daily activity and participation, with three possible answers for each item: 'still doing,' 'stopped doing,' or 'never did.' For each item, the participant will have to choose one of these responses. Based on each answer, two scores will be calculated: the Maximal Activity Score (MAS), which corresponds to the activity with the highest effort demand that the volunteer 'still performs'; and the Adjusted Activity Score (AAS), which will be calculated by subtracting the number of items the subject 'has stopped doing' below the MAS value from the MAS itself. The AAS will provide the value of activity that the subject has ceased to perform compared to what they were doing before. Unit of Measure: Absolute number.
Measured: Baseline
Screening Sarcopenia risk
Screening for Sarcopenia risk will be performed using the "Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls" (SARC-F) questionnaire, which consists of five self-reported questions based on the subjects' perception of their limitations regarding strength, walking ability, rising from a chair, climbing stairs, and their history and number of falls. Each item will be scored from 0 to 2, where 0 = no difficulty, 1 = some difficulty, and 2 = great difficulty, or if the subject uses devices or cannot perform the task without personal assistance. The total SARC-F score can range from 0 to 10, and subjects with a score ≥ 4 points will be considered at risk of sarcopenia, in accordance with the recommendations of the European consensus on sarcopenia. Unit of Measure: Absolute number.
Measured: Baseline
Frailty assessment using the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire
Frailty will be assessed using the five questions (fatigue, climbing stairs, walking 100 m, comorbidity, and weight loss) that comprise the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire. A score of 1 or higher suggests frailty. Unit of Measure: Absolute Number
Measured: Baseline
Frailty assessment using the Fried Frailty Phenotype
Frailty will be assessed using the five components (weight loss, handgrip weakness, fatigue, low physical activity, and gait speed) of the Fried Frailty Phenotype. A score of 1 or higher suggests frailty. Unit of Measure: Absolute number
Measured: Baseline
4-metre gait speed assessment
The 4-metre gait speed test will be performed preferably before the second HD session of the week, in a corridor of the unit. Patients will be asked to walk between two marks at their usual pace, using walking aids if necessary. A practice trial will be provided, and the times of two trials will be recorded in seconds and converted to m/s. The best of the two trials will be used for analysis. Unit of Measure: Absolute number
Measured: Baseline
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) will be assessed using the Spanish version of the Medical Outcomes Study Short Form-36 (SF-36) questionnaire . Scores range from 0 to 100, with higher scores indicating better HRQoL. Results are reported across eight subscales (physical functioning, vitality, role physical, general health, social functioning, mental health, role emotional, and bodily pain) and two summary components (physical and mental components). Unit of Measure: Absolute number
Measured: Baseline
Sit-to-Stand-to-Sit tests- 10 repetitions (STS-10) and Sit-to-Stand-to-Sit tests 60 seconds (STS-60)
The Sit-to-Stand-to-Sit- 10 (STS-10) and Sit-to-Stand-to-Sit-60 (STS-60) tests will be performed preferably before the second or third HD session. Participants will be seated in a chair with their arms crossed over the chest, feet on the floor, and back supported against the backrest whenever possible. The chair must be stable and placed against a wall to minimize the risk of falls. Participants will be asked to keep their arms crossed to avoid using them for assistance and, with their feet on the ground, to stand up and sit down 10 consecutive times as quickly as possible. The time required to complete the test will be recorded in seconds.
After a rest period following the STS-10, the same procedure will be performed for the STS-60, in which the number of repetitions completed in 60 seconds will be recorded. Both the number of repetitions and the Rating of Perceived Exertion (RPE) will be documented.
Unit of measure: absolute number
Measured: Baseline
Assessment of muscle thickness
Muscle quantity and quality will be evaluated using ultrasound measurement of the cross-sectional area of the rectus femoris muscle, performed 30 minutes after the start of HD, on a different day from the muscle strength assessments. The assessment will be conducted on the dominant lower limb, with the participant in the supine position, the limb fully extended, and the muscles relaxed. It will be measured muscle thickness, (unit of measure: millimeter).
Measured: Baseline
Assessment of muscle cross-sectional area
Muscle quantity and quality will be evaluated using ultrasound measurement of the cross-sectional area of the rectus femoris muscle, performed 30 minutes after the start of HD, on a different day from the muscle strength assessments. The assessment will be conducted on the dominant lower limb, with the participant in the supine position, the limb fully extended, and the muscles relaxed. It will be measured muscle cross-sectional area ( unit of measure: millimeter squared).
Measured: Baseline
Assessment of muscle subcutaneous fat thickness
Muscle quantity and quality will be evaluated using ultrasound measurement of the cross-sectional area of the rectus femoris muscle, performed 30 minutes after the start of HD, on a different day from the muscle strength assessments. The assessment will be conducted on the dominant lower limb, with the participant in the supine position, the limb fully extended, and the muscles relaxed. It will be measured muscle subcutaneous fat thickness, (unit of measure: millimeter).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease on HemodialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Medizinisches Versorgungszentrum Diaverum Potsdam
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva Ms Segura Ortí, Professor, Study chair, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642778
- Sponsor's protocol ID
- CEEI26/84
- Acronym
- REHAD- CKD
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sabatino A, Regolisti G, Delsante M, Di Motta T, Cantarelli C, Pioli S, Grassi G, Batini V, Gregorini M, Fiaccadori E. Noninvasive evaluation of muscle mass by ultrasonography of quadriceps femoris muscle in End-Stage Renal Disease patients on hemodialysis. Clin Nutr. 2019 Jun;38(3):1232-1239. doi: 10.1016/j.clnu.2018.05.004. Epub 2018 May 19.
PubMed 29866494Johansen KL, Painter P, Kent-Braun JA, Ng AV, Carey S, Da Silva M, Chertow GM. Validation of questionnaires to estimate physical activity and functioning in end-stage renal disease. Kidney Int. 2001 Mar;59(3):1121-7. doi: 10.1046/j.1523-1755.2001.0590031121.x.
PubMed 11231369Segura-Orti E, Junque-Jimenez A, Dubuis V, Reboredo MM, Benavent-Caballer V, Valtuena-Gimeno N, Barros FS, Silva DT, Martinez-Olmos FJ. Handheld Dynamometry Testing During Dialysis: Intrarater and Interrater Reliability Study. J Ren Nutr. 2025 May;35(3):433-442. doi: 10.1053/j.jrn.2025.01.002. Epub 2025 Jan 24.
PubMed 39864471Junque Jimenez A, Esteve Simo V, Andreu Periz L, Segura Orti E. The Relationship between Physical Activity Levels and Functional Capacity in Patients with Advanced Chronic Kidney Disease. Clin Nurs Res. 2021 Mar;30(3):360-368. doi: 10.1177/1054773820907757. Epub 2020 Feb 19.
PubMed 32075428Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.
PubMed 28114792
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for Lower-Limb Dynamometry in Patients With Chronic Kidney Disease (REHAD-CKD)
- ClinicalTrials.gov ID
- NCT07642778
- Acronym / sponsor ID
- REHAD- CKD / CEEI26/84
- Conditions
- Chronic Kidney Disease on Hemodialysis
- Keywords
- Chronic Kidney Disease, Lower limb strength, Intradialytic assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Medizinisches Versorgungszentrum Diaverum Potsdam
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2026 (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.
Patients with chronic kidney disease (CKD) undergoing hemodialysis present musculoskeletal complications, such as sarcopenia, which impair their functionality and are associated with an increased risk of mortality. Functional assessment in this population is complex due to the organization of hemodialysis schedules and patients' dependence on medical transportation, which hinders evaluation outside the dialysis setting.
The assessment of lower limb strength is of great relevance, as an adequate level of muscle strength in this region is essential for performing many activities of daily living, including walking, sit-to-stand and stand-to-sit movements, as well as ascending and descending stairs. Our research group has published a study demonstrating the safety and reliability of intradialytic measurement of hip flexion and abduction strength; however, reference values for the dialysis population and for individuals with CKD in general are currently unknown.
The primary aim of this study is to propose reference values for hip flexor and abductor muscle strength measured using a hand-held dynamometer in individuals with chronic kidney disease (CKD). Secondary objectives include assessing the association between lower limb muscle strength measured with a hand-held dynamometer and handgrip strength, physical activity level, frailty, gait speed, performance in the 10-repetition sit-to-stand-to-sit test, ultrasound assessment of the rectus femoris muscle, and health-related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REHAB-CKD group | – | –The target population of the present study consists of patients with chronic kidney disease undergoing hemodialysis in DIAVERUM centers in Spain. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD undergoing HD in DIAVERUM centers in Spain, male and female, aged 18 and older, who have been on dialysis for more than one month.
Key inclusion criteria (1 listed)
- ≥1 months on HD (3 weekly sessions of 4 hours)
Key exclusion criteria (6 listed)
- Lower-limb amputation;
- Neurological, musculoskeletal or osteoarticular disorders;
- Severe/unstable comorbidities (e.g., decompensated heart failure or diabetes, unstable angina, recent MI, uncontrolled hypertension, severe lung disease, acute infection);
- <1 months on HD;
- <2 sessions/week,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference values for Lower Limb Strengh
Time frame: Baseline
Lower limb strengh will be evaluated using handheld dynamometer (Lafayette Manual Muscle Testing System Model-01165, Lafayette IN, USA) for hip flexors and hip abductors.Testing will follow a strict structured order: first hip flexors and then hip abductors. Within each muscle group, legs will be alternated, starting with the dominant leg and then the nondominant leg, to allow specific rest periods between muscle groups (15 seconds). Hip flexors will be assessed with the patients with both hips and knees bent. The dynamometer will be placed on the anterior part of the thigh, 2 centimetres below of patella. Hip abductors will be assessed with both legs extended at the hip and knee. The dynamometer will be placed on the lateral part of the thigh, 2 centimetres below of the knee joint line. During both measurements physiotherapist will apply force in the opposite direction of the movement. Unit of measure: Newton (N).
11 secondary outcomes
Muscle strength assessment Handgrip
Time frame: Baseline
Human Activity Profile
Time frame: Baseline
Screening Sarcopenia risk
Time frame: Baseline
Frailty assessment using the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire
Time frame: Baseline
Frailty assessment using the Fried Frailty Phenotype
Time frame: Baseline
4-metre gait speed assessment
Time frame: Baseline
Health-related quality of life (HRQoL)
Time frame: Baseline
Sit-to-Stand-to-Sit tests- 10 repetitions (STS-10) and Sit-to-Stand-to-Sit tests 60 seconds (STS-60)
Time frame: Baseline
Assessment of muscle thickness
Time frame: Baseline
Assessment of muscle cross-sectional area
Time frame: Baseline
Assessment of muscle subcutaneous fat thickness
Time frame: Baseline
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 12 Jun 2026.
- Background: PubMed 29866494Sabatino A, Regolisti G, Delsante M, Di Motta T, Cantarelli C, Pioli S, Grassi G, Batini V, Gregorini M, Fiaccadori E. Noninvasive evaluation of muscle mass by ultrasonography of quadriceps femoris muscle in End-Stage Renal Disease patients on hemodialysis. Clin Nutr. 2019 Jun;38(3):1232-1239. doi: 10.1016/j.clnu.2018.05.004. Epub 2018 May 19.
- Background: PubMed 11231369Johansen KL, Painter P, Kent-Braun JA, Ng AV, Carey S, Da Silva M, Chertow GM. Validation of questionnaires to estimate physical activity and functioning in end-stage renal disease. Kidney Int. 2001 Mar;59(3):1121-7. doi: 10.1046/j.1523-1755.2001.0590031121.x.
- Background: PubMed 39864471Segura-Orti E, Junque-Jimenez A, Dubuis V, Reboredo MM, Benavent-Caballer V, Valtuena-Gimeno N, Barros FS, Silva DT, Martinez-Olmos FJ. Handheld Dynamometry Testing During Dialysis: Intrarater and Interrater Reliability Study. J Ren Nutr. 2025 May;35(3):433-442. doi: 10.1053/j.jrn.2025.01.002. Epub 2025 Jan 24.
- Background: PubMed 32075428Junque Jimenez A, Esteve Simo V, Andreu Periz L, Segura Orti E. The Relationship between Physical Activity Levels and Functional Capacity in Patients with Advanced Chronic Kidney Disease. Clin Nurs Res. 2021 Mar;30(3):360-368. doi: 10.1177/1054773820907757. Epub 2020 Feb 19.
- Background: PubMed 28114792Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
Eva Ms Segura Ortí, Professor study chair
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease on 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Jun 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?
Contact Eva Ms Segura Ortí, Professor (+34671580094, esegura@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference values for Lower Limb Strengh (time frame: Baseline). 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 NCT07642778, which also lists 5 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 12 Jun 2026.