SarcopeniaNCT07447375
Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality
A study testing Intradialytic Personalized Exercise Program. in people with Sarcopenia and Renal Insufficiency, Chronic, run by University of Salamanca at 1 site in Spain.
Trial summary
Sarcopenia (the loss of muscle mass, strength, and function) is highly prevalent in patients with Chronic Kidney Disease (CKD) undergoing hemodialysis, significantly increasing the risk of falls, frailty, and mortality. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sarcopenia, Renal Insufficiency, Chronic
- What is being tested?
- Intradialytic Personalized Exercise Program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2026to 30 Jun 2027
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects currently enrolled in a Chronic Hemodialysis Unit.
- Patients who have been on hemodialysis treatment for more than 3 months.
- Subjects aged 40 years or older.
- Hemoglobin levels greater than 10 mg/dl.
- Ability to perform physical fitness assessment tests or dynamometry.
- Willingness and ability to provide signed informed consent
Who cannot join
- Presence of intradialytic instability.
- Medical conditions where exercise is contraindicated: active infectious process, neoplasms, uncontrolled arrhythmias, or left ventricular dysfunction (EF < 35%).
- Musculoskeletal or respiratory alterations that worsen with exercise.
- Lower limb amputation without a prosthesis.
- Cerebrovascular disease (stroke with sequelae or transient ischemic attacks within the previous 6 weeks).
- Uncontrolled hypertension (Systolic BP > 200 mmHg or Diastolic BP > 120 mmHg).
Show all 14Show fewer
- Unstable angina (at rest or during exercise) or history of coronary bypass/ischemic heart disease within the previous 6 weeks.
- Diabetes mellitus with severe decompensation (blood glucose > 300 mg/dl).
- Dialysis-related hypotension (mean blood pressure < 90/70 mmHg).
- Psychiatric or cognitive alterations that prevent collaboration with muscle training programs.
- Presence of an arteriovenous fistula in a lower limb.
- Motor neurological injury causing dysfunction that prevents the application of the strength protocol.
- Hospitalization within the 3 months prior to the study.
- Lack of cooperation (defined as failing to attend more than 25% of sessions) or inability to understand the treatment.
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
Universidad de Salamanca
Salamanca, Salamanca, 37008
María de la Luz Sánchez Tocino, PhD, +34 625067971, mlsancheztocino@usal.es
About this study
Official title: Intrahospital Exercise Program in Hemodialysis Patients: Impact on Sarcopenia Markers, Sleep Quality, and Quality of Life.
Sarcopenia (the loss of muscle mass, strength, and function) is highly prevalent in patients with Chronic Kidney Disease (CKD) undergoing hemodialysis, significantly increasing the risk of falls, frailty, and mortality. Despite its impact, there is a lack of evidence regarding the effectiveness of exercise programs specifically designed to address sarcopenia under the latest international diagnostic criteria (EWGSOP2) in older renal patients.
The primary objective of this randomized controlled clinical trial is to evaluate the effects of a 12-week supervised intrahospital exercise program on muscle mass, strength, and physical performance in hemodialysis patients over 40 years of age. Additionally, the study aims to analyze how this intervention influences sleep quality-often disrupted in this population-and overall health-related quality of life.
Read more
Participants will be randomly assigned to either an Intervention Group, which will perform personalized strength and aerobic exercises during the first 90 minutes of their dialysis sessions, or a Control Group, receiving standard care. Evaluations will be conducted at three points: baseline (pre-randomization), at 12 weeks (post-intervention).
The investigators hypothesize that integrating physical exercise into the routine clinical care of hemodialysis patients will improve sarcopenia markers and sleep patterns, leading to greater functional independence and better clinical outcomes.
- Conditions
- Sarcopenia, Renal Insufficiency, Chronic
- Being tested
- Intradialytic Personalized Exercise Program.
- Keywords
- Hemodialysis, Intradialytic Exercise, Sleep Quality, Quality of Life
- Medical subject headings
- Sarcopenia, Renal Insufficiency, Chronic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic Personalized Exercise Program.Behavioural
Personalized intradialytic exercise program performed during the first 30 minutes of the hemodialysis session once the patient is hemodynamically stable. The intervention lasts 12 weeks with 2-3 sessions per week, supervised by physiotherapists. Each session (max. 60 min) includes: 1) Respiratory and joint mobility warm-up; 2) Strength training for lower limbs (hip flexors, extensors, abduction/adduction, and ankle movements) using elastic bands, weighted ankle straps, foam balls, and Pilates rings; 3) Aerobic resistance using a bed-cycle ergometer. Intensity is adjusted progressively to 12-14 on the Borg Scale (range 6-20). The program follows training principles, increasing volume and intensity over time to improve muscle mass, strength, and physical performance.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention : Control group | No intervention | Not described |
| Experimental: Intervention Group | Experimental | Intradialytic exercise program (strength and aerobic) 3 times weekly for 3 months. Receives: Behavioral: Intradialytic Personalized Exercise Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
> Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry.
> Muscle strength is assessed using a CAMRYR electronic dynamometer (Model EH101). The participant is in a standing position with the arm extended and parallel to the body. Maximum grip strength is measured over 3 seconds. Two attempts are made for each arm, and the highest value from the dominant arm (measured in kilograms) is recorded.
Measured: > Baseline, 12 weeks (post-intervention)
Change in Lower Limb Muscle Strength measured by the 5-Times Sit-to-Stand Test (STS5).
The STS5 test measures the time (in seconds) required for the patient to rise from a chair 5 consecutive times without arm support. It is a proxy for lower extremity muscle strength and power. A decrease in the time taken indicates an improvement in muscle function.
Measured: Baseline, 12 weeks (post-intervention)
Change in Appendicular Skeletal Muscle Mass (ASMM) measured by Bioelectrical Impedance Analysis (BIA).
Assessment of body composition and muscle mass using a portable BIA device. This method provides a validated estimate of muscle mass in both ambulatory and bedridden patients. The study focuses on the Appendicular Skeletal Muscle Mass (ASMM), which is essential for confirming a diagnosis of sarcopenia according to EWGSOP2 criteria. Higher values reflect greater muscle mass.
Measured: Baseline, 12 weeks (post-intervention)
Change in Physical Performance measured by the Short Physical Performance Battery (SPPB).
The SPPB is a composite score (0 to 12 points) evaluating balance, gait speed (4 meters), and the sit-to-stand test. A total score of 8 or less identifies patients with severe sarcopenia or high risk of frailty. Higher scores indicate better physical performance.
Measured: Baseline, 12 weeks (post-intervention)
Change in Sleep Quality measured by the Pittsburgh Sleep Quality Index (PSQI).
A self-administered questionnaire that assesses sleep quality over a 1-month time interval. It consists of 19 individual items, creating 7 components that yield one global score (range 0 to 21). Lower scores denote better sleep quality.
Measured: Baseline, 12 weeks (post-intervention)
Secondary outcomes (4)
> Change in Sarcopenia-related Quality of Life measured by the SarQoL® Questionnaire.
> The Sarcopenia Quality of Life (SarQoL®) is a self-administered questionnaire specifically developed for patients with sarcopenia. It consists of 22 questions covering 55 items across 7 domains: physical and mental health, mobility, body composition, function, activities of daily living, leisure activities, and fears. The total score ranges from 0 to 100, where higher scores indicate a better quality of life.
Measured: > Baseline, 12 weeks (post-intervention)
Objective Sleep Assessment via Wrist-worn Accelerometry (Actigraph).
Objective measurement of sleep-wake patterns using the Actigraph GT3X+ accelerometer. This device, worn on the wrist for 5 consecutive days, captures continuous data on circadian rhythms and physical activity. Using validated scoring algorithms via Actilife 6 software, the following statistics will be calculated: Total Sleep Time (TST), Sleep Efficiency (percentage of time in bed spent sleeping), and Wake After Sleep Onset (WASO).
Measured: Baseline, 12 weeks (post-intervention)
Change in Fat Mass Percentage measured by Bioelectrical Impedance Analysis (BIA).
Measurement of the total proportion of body fat relative to total body weight. This parameter is used to evaluate changes in body composition and to identify the presence of sarcopenic obesity in hemodialysis patients. A decrease in fat mass percentage is generally associated with improved metabolic health in this population.
Measured: Baseline, 12 weeks (post-intervention).
Change in Total Body Water (TBW) Percentage measured by Bioelectrical Impedance Analysis (BIA).
Evaluation of the percentage of total body water, including intracellular and extracellular compartments. In hemodialysis patients, this measure is crucial to ensure that changes in muscle mass measurements are not confounded by variations in hydration status or fluid overload between sessions.
Measured: Baseline, 12 weeks (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Gerencia Regional de Salud de Castilla y Leon, Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Principal investigator, José Ignacio Recio Rodriguez, University of Salamanca
- Investigators
- María de la Luz Sánchez Tocino, Study director, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447375
- Sponsor's protocol ID
- GRS 3142/A1/2024
- Other IDs
- GRS 3142/A1/2024
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrahospital Exercise Program in Hemodialysis Patients: Impact on Sarcopenia Markers, Sleep Quality, and Quality of Life.
- ClinicalTrials.gov ID
- NCT07447375
- Acronym / sponsor ID
- GRS 3142/A1/2024
- Conditions
- Sarcopenia, Renal Insufficiency, Chronic
- Keywords
- Hemodialysis, Intradialytic Exercise, Sleep Quality, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Gerencia Regional de Salud de Castilla y Leon, Instituto de Investigación Biomédica de Salamanca
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Mar 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.
Sarcopenia (the loss of muscle mass, strength, and function) is highly prevalent in patients with Chronic Kidney Disease (CKD) undergoing hemodialysis, significantly increasing the risk of falls, frailty, and mortality. Despite its impact, there is a lack of evidence regarding the effectiveness of exercise programs specifically designed to address sarcopenia under the latest international diagnostic criteria (EWGSOP2) in older renal patients.
The primary objective of this randomized controlled clinical trial is to evaluate the effects of a 12-week supervised intrahospital exercise program on muscle mass, strength, and physical performance in hemodialysis patients over 40 years of age. Additionally, the study aims to analyze how this intervention influences sleep quality-often disrupted in this population-and overall health-related quality of life.
Participants will be randomly assigned to either an Intervention Group, which will perform personalized strength and aerobic exercises during the first 90 minutes of their dialysis sessions, or a Control Group, receiving standard care. Evaluations will be conducted at three points: baseline (pre-randomization), at 12 weeks (post-intervention).
The investigators hypothesize that integrating physical exercise into the routine clinical care of hemodialysis patients will improve sarcopenia markers and sleep patterns, leading to greater functional independence and better clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention : Control group | No intervention | – |
| Experimental: Intervention Group | Experimental | Behavioral: Intradialytic Personalized Exercise Program.Intradialytic exercise program (strength and aerobic) 3 times weekly for 3 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects currently enrolled in a Chronic Hemodialysis Unit.
- Patients who have been on hemodialysis treatment for more than 3 months.
- Subjects aged 40 years or older.
- Hemoglobin levels greater than 10 mg/dl.
- Ability to perform physical fitness assessment tests or dynamometry.
Key exclusion criteria (14 listed)
- Presence of intradialytic instability.
- Medical conditions where exercise is contraindicated: active infectious process, neoplasms, uncontrolled arrhythmias, or left ventricular dysfunction (EF < 35%).
- Musculoskeletal or respiratory alterations that worsen with exercise.
- Lower limb amputation without a prosthesis.
- Cerebrovascular disease (stroke with sequelae or transient ischemic attacks within the previous 6 weeks).
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 |
|---|---|---|
| Intradialytic Personalized Exercise Program.Personalized intradialytic exercise program performed during the first 30 minutes of the hemodialysis session once the patient is hemodynamically stable. The intervention lasts 12 weeks with 2-3 sessions per week, supervised by physiotherapists. Each session (max. 60 min) includes: 1) Respiratory and joint mobility warm-up; 2) Strength training for lower limbs (hip flexors, extensors, abduction/adduction, and ankle movements) using elastic bands, weighted ankle straps, foam balls, and Pilates rings; 3) Aerobic resistance using a bed-cycle ergometer. Intensity is adjusted progressively to 12-14 on the Borg Scale (range 6-20). The program follows training principles, increasing volume and intensity over time to improve muscle mass, strength, and physical performance. | Behavioural | Experimental: Intervention Group |
Primary outcome
> Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry.
Time frame: > Baseline, 12 weeks (post-intervention)
> Muscle strength is assessed using a CAMRYR electronic dynamometer (Model EH101). The participant is in a standing position with the arm extended and parallel to the body. Maximum grip strength is measured over 3 seconds. Two attempts are made for each arm, and the highest value from the dominant arm (measured in kilograms) is recorded.
Change in Lower Limb Muscle Strength measured by the 5-Times Sit-to-Stand Test (STS5).
Time frame: Baseline, 12 weeks (post-intervention)
The STS5 test measures the time (in seconds) required for the patient to rise from a chair 5 consecutive times without arm support. It is a proxy for lower extremity muscle strength and power. A decrease in the time taken indicates an improvement in muscle function.
Change in Appendicular Skeletal Muscle Mass (ASMM) measured by Bioelectrical Impedance Analysis (BIA).
Time frame: Baseline, 12 weeks (post-intervention)
Assessment of body composition and muscle mass using a portable BIA device. This method provides a validated estimate of muscle mass in both ambulatory and bedridden patients. The study focuses on the Appendicular Skeletal Muscle Mass (ASMM), which is essential for confirming a diagnosis of sarcopenia according to EWGSOP2 criteria. Higher values reflect greater muscle mass.
Change in Physical Performance measured by the Short Physical Performance Battery (SPPB).
Time frame: Baseline, 12 weeks (post-intervention)
The SPPB is a composite score (0 to 12 points) evaluating balance, gait speed (4 meters), and the sit-to-stand test. A total score of 8 or less identifies patients with severe sarcopenia or high risk of frailty. Higher scores indicate better physical performance.
Change in Sleep Quality measured by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Baseline, 12 weeks (post-intervention)
A self-administered questionnaire that assesses sleep quality over a 1-month time interval. It consists of 19 individual items, creating 7 components that yield one global score (range 0 to 21). Lower scores denote better sleep quality.
4 secondary outcomes
> Change in Sarcopenia-related Quality of Life measured by the SarQoL® Questionnaire.
Time frame: > Baseline, 12 weeks (post-intervention)
Objective Sleep Assessment via Wrist-worn Accelerometry (Actigraph).
Time frame: Baseline, 12 weeks (post-intervention)
Change in Fat Mass Percentage measured by Bioelectrical Impedance Analysis (BIA).
Time frame: Baseline, 12 weeks (post-intervention).
Change in Total Body Water (TBW) Percentage measured by Bioelectrical Impedance Analysis (BIA).
Time frame: Baseline, 12 weeks (post-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 3 Mar 2026.
- 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.
María de la Luz Sánchez Tocino study director
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic Personalized Exercise Program. in people with Sarcopenia and Renal Insufficiency, Chronic, run by University of Salamanca 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 6 inclusion and 14 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 3 Mar 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 María de la Luz Sánchez Tocino, PhD (+34 625067971, mlsancheztocino@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
> Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry. (time frame: > Baseline, 12 weeks (post-intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.