An interventional study of Online Therapeutic Exercise Programme and Usual Care Control Group in Kidney Transplantation, Physical Function and Muscle Weakness Condition, sponsored by Cardenal Herrera University. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment
Kidney transplant recipients frequently experience reduced physical function, muscle weakness, low levels of physical activity, and an increased risk of cardiovascular and metabolic complications, despite improvements in survival and quality of life following transplantation. Therapeutic exercise has been shown to improve cardiorespiratory fitness, muscle strength, and physical function in this population. However, access to supervised rehabilitation programmes after transplantation remains limited. Online exercise programmes may provide an accessible and feasible alternative, particularly for patients who face geographical or logistical barriers to attending supervised in-person sessions.
This pilot randomized controlled trial aims to evaluate the feasibility and safety of a supervised group-based online therapeutic exercise programme for transplant recipients. Participants will be randomly allocated to either a control group receiving usual care or an intervention group participating in a supervised online exercise programme. Secondary outcomes will include muscle strength, physical function, physical activity, sarcopenia, frailty, muscle characteristics, anthropometric measures, body composition, and biochemical parameters.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Cardenal Herrera University is the lead sponsor of 107 studies on the registry; 22 are open to participants now.
Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to the intervention group will participate in a supervised group-based online therapeutic exercise programme delivered via Microsoft Teams for 24 weeks.
Behavioral: Online Therapeutic Exercise Programme
Participants allocated to the control group will continue with their usual activities and usual care throughout the 24-week study period and will not participate in the supervised online therapeutic exercise programme.
Behavioral: Usual Care Control Group
Participants will complete three supervised online exercise sessions per week for 24 weeks. Each session will last approximately 30-40 minutes and will include lower-limb resistance exercises targeting the major muscle groups, brisk walking intervals, and progressive balance exercises. Exercise difficulty will be individualized by the physiotherapist according to perceived exertion. Heart rate, blood pressure, and rating of perceived exertion will be monitored during the intervention.
Participants randomized to the control group will maintain their usual activities and standard care throughout the 24-week intervention period. They will not receive the supervised online therapeutic exercise intervention.
Recruitment Rate
The percentage of eligible individuals who are enrolled in the study.
Time frame: During the recruitment period, up to 2 months
Adherence to the Online Exercise Programme
Adherence will be calculated as the percentage of exercise sessions completed by each participant relative to the total number of sessions scheduled during the 24-week intervention.
Time frame: Throughout the 24-week intervention
Participant Retention Rate
The percentage of enrolled participants who complete the final study assessment relative to the total number of participants initially enrolled.
Time frame: At 24 weeks
Number of Adverse Events During the Exercise Programme
Safety will be assessed by recording adverse events occurring during exercise sessions, including musculoskeletal injuries, cardiovascular symptoms, exercise intolerance, or any event requiring modification or temporary suspension of the intervention.
Time frame: Throughout the 24-week intervention
Lower-Limb Muscle Strength Assessed by Hand-Held Dynamometry
Maximal isometric strength of the hip flexors and hip abductors will be assessed using hand-held dynamometry. Three maximal voluntary contractions will be performed for each muscle group, and the maximum value will be recorded in kilogram-force (kgf).
Time frame: Baseline, 4 weeks, 3 months, and 6 months
Handgrip Strength
Handgrip strength will be assessed using a Jamar® hydraulic dynamometer. Three maximal voluntary contractions will be performed with each hand, and the maximum value will be recorded in kilograms (kg).
Time frame: Baseline, 3 months, and 6 months
60-Second Sit-to-Stand Test Performance
Functional capacity will be assessed using the 60-Second Sit-to-Stand Test (STS-60). The total number of complete sit-to-stand repetitions performed within 60 seconds will be recorded. A higher number of repetitions indicates better functional performance.
Time frame: Baseline, 3 months, and 6 months
Timed Up and Go Test Performance
Functional mobility and dynamic balance will be assessed using the Timed Up and Go (TUG) test. The time required to stand from a chair, walk 3 metres, turn, return, and sit down will be recorded in seconds.
Time frame: Baseline, 3 months, and 6 months
6-Minute Walk Test Distance
Walking capacity will be assessed using the 6-Minute Walk Test (6MWT). The total distance walked during 6 minutes will be recorded in metres (m).
Time frame: Baseline, 3 months, and 6 months
Physical Activity Assessed by the Human Activity Profile
Physical activity will be assessed using the Human Activity Profile (HAP). The Adjusted Activity Score (AAS) will be recorded.
Time frame: Baseline, 3 months, and 6 months
Change in Risk of Sarcopenia Assessed by SARC-F
Risk of sarcopenia will be assessed using the SARC-F questionnaire. The total score ranges from 0 to 10, with a score ≥4 indicating risk of sarcopenia.
Time frame: Baseline, 3 months, and 6 months
Frailty Assessed by the FRAIL Scale
Frailty will be assessed using the FRAIL scale. Scores range from 0 to 5, with a score ≥3 indicating frailty.
Time frame: Baseline, 3 months, and 6 months
Rectus Femoris Muscle Characteristics Assessed by Ultrasound
Musculoskeletal ultrasound will be used to assess rectus femoris muscle thickness (mm), cross-sectional area (cm²), and muscle echogenicity.
Time frame: Baseline, 3 months, and 6 months
Anthropometric Measurements
Waist circumference, upper-arm circumference, and calf circumference will be measured using standardised procedures and recorded in centimetres (cm).
Time frame: Baseline, 3 months, and 6 months
Body Composition Assessed by Bioelectrical Impedance Vector Analysis
Body composition will be assessed using bioelectrical impedance vector analysis (BIVA), including muscle mass.
Time frame: Baseline, 3 months, and 6 months
T3
Triiodothyronine (T3) is the primary biologically active form of thyroid signaling molecules. Measures both bound and free T3 combined. (ng/dL)
Time frame: Baseline, 3 months, and 6 months
T4
Thyroxine (T4) is one of the two main hormones produced by the thyroid gland.(mcg/dL)
Time frame: Baseline, 3 months, and 6 months
Testosterone
Testosterone is the primary male sex hormone (androgen), although it is also present and essential in females in much smaller amounts. It is a steroid hormone synthesized primarily from cholesterol; (ng/dL :nanograms per deciliter)
Time frame: Baseline, 3 months, and 6 months
Cortisol
Cortisol is a steroid hormone produced by the adrenal glands (located on top of each kidney) that is essential for life and regulates a wide range of vital processes throughout the body.
Time frame: Baseline, 3 months, and 6 months
Estrogens
Estrogens are a group of hormones crucial for sexual and reproductive development, primarily in women.Estrogen levels are typically measured via a blood test and reported in picograms per milliliter (pg/mL) or picomoles per liter (pmol/L).
Time frame: Baseline, 3 months, and 6 months
Progesterone
Progesterone is an endogenous 21-carbon steroid hormone derived from cholesterol. It is primarily classified as a progestogen (the main one in the human body) and plays a fundamental role in regulating the menstrual cycle, supporting early pregnancy, and promoting embryogenesis.
Time frame: Baseline, 3 months, and 6 months
Fasting glucose
Fasting glucose (glicemia a digiuno) is a blood test that measures the amount of sugar (glucose) in your blood after an overnight fast (usually 8 to 12 hours without eating or drinking anything except water). It is primarily used to screen for and diagnose prediabetes and diabetes.Fasting glucose is typically measured in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L).
Time frame: Baseline, 3 months, and 6 months
Creatinine
Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Your kidneys filter creatinine from your blood and excrete it through urine. Measuring creatinine levels is the most common way to assess how well your kidneys are functioning.Milligrams per deciliter (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Estimated glomerular filtration rate
The Estimated Glomerular Filtration Rate (eGFR) is a blood test that estimates how well your kidneys are filtering waste. It is the primary metric used by medical professionals to determine your level of kidney function and to stage Chronic Kidney Disease (CKD). The measurement is reported in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m²).
Time frame: Baseline, 3 months, and 6 months
C-reactive protein
C-reactive protein (CRP) is a protein made by the liver that increases when there is active inflammation or infection in the body.CRP is typically measured in milligrams per liter (mg/L) or milligrams per deciliter (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Albumin
Albumin is the most abundant circulating protein found in blood plasma, representing about 50% to 60% of all plasma proteins. Synthesized exclusively by the liver, it performs two vital biological functions: maintaining oncotic pressure (which keeps fluid from leaking out of blood vessels into surrounding tissues) and transporting molecules like hormones, fatty acids, bilirubin, medications, and ions throughout the body. Normal Adult Reference Range: 3.4 to 5.4 g/dL (grams per deciliter) or 34 to 54 g/L (grams per liter).
Time frame: Baseline, 3 months, and 6 months
Total cholesterol
Total cholesterol is a measurement of the total amount of cholesterol in your blood. It is a waxy, fat-like substance that your body needs to build healthy cells, but having too much of it can increase your risk of heart disease.mg/dL (milligrams per deciliter).
Time frame: Baseline, 3 months, and 6 months
A Complete Blood Count (CBC)
A Complete Blood Count (CBC) is a standard blood test that evaluates your overall health and detects a wide range of disorders, including anemia, infection, and leukemia. It measures the three primary types of cells in your blood: red blood cells, white blood cells, and platelets.
Time frame: Baseline, 3 months, and 6 months
Albuminuria
Albuminuria is a pathological condition characterized by the abnormal presence of albumin-a primary plasma protein-in the urine. (mg/day)
Time frame: Baseline, 3 months, and 6 months
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 6 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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