Chronic Kidney DiseasesFrailmarNCT04701398
Multimodal Prehabilitation in Frail and Non-frail Patients Waiting for a Kidney Transplantation (the FRAILMAR Study)
A study testing Multimodal prehabilitation in people with Chronic Kidney Diseases, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Frailty is very frequent among patients waiting for a kidney transplantation (KT). Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Multimodal prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults patients with chronic kidney disease
- Inclusion in the waiting list for deceased donor kidney transplantation in the period September 2020 to August 2022
Who cannot join
- Patients unable to perform the exercise plan or giving informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
Ester Marco, MD PhD, +34699706860, emarco@parcdesalutmar.cat
Julio Pascual Santos, MD PhD
About this study
Official title: Frailty in Patients With Advanced Chronic Kidney Disease Waiting for a Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.
Frailty is very frequent among patients waiting for a kidney transplantation (KT). Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Frailty in patients with chronic kidney disease (CKD) displays a constellation of features that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. A pre-transplant intervention including physical therapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.
The main objective is to assess effectiveness, feasibility and safety of a prehabilitation program (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates on clinical and functional outcomes after KT.
Read the detailed description
Frailty is very frequent among patients with chronic kidney disease (CKD) included in the waiting list for deceased donor kidney transplantation (KT), and outcomes are worsened in those frail recipients after KT. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcareutilization after KT. Frailty in CKD patients displays a unique constellation of features such as muscle wasting, anorexia, protein energy wasting, inflammation, oxidative stress, catabolic/anabolic hormone imbalance, metabolic acidosis, and other cellularalterations that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. Efforts to intervene with post- transplant physical therapy have been met with limited success, in large part due to high study dropout. A pre-transplant clinical framework for multimodal prehabilitation interventions including physicaltherapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention andcompliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.
The main objective of this study is to assess effectiveness, feasibility and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates in the context of a randomized controlled clinical trial. The primary endpoint will be a composite achievement of clinical and functional outcomes in frail and non-frail KT candidates after KT.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Multimodal prehabilitation
- Keywords
- chronic kidney disease, kidney transplantation, frailty, prehabilitation, exercise, nutritional status, psychological advice, sarcopenia
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitationOther
Exercise + nutritional supplementation + psychological advice
| Study group | Role | What they receive |
|---|---|---|
| Multimodal intervention | Experimental | supervised physical training (1-hour sessions, 24 sessions, 8 weeks) + nutritional supplementation + psychological advice Receives: Other: Multimodal prehabilitation |
| Standard Care | No intervention | Healthy living recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bad-Outcome Composite Endpoint
Delayed draft function >14 days + never functioning kidney + non-elective readmission before day 90 + surgical complications (wound healing problems, obstructive lymphocele, vascular thrombosis, urinary stenosis or leak, acute hemorrhage, immediate re-intervention) + discharge to an assisted facility + all-cause death.
Measured: 90 days post-kidney transplantation
Secondary outcomes (9)
Changes in exercise capacity
Changes in peak oxygen uptake (higher scores mean better outcome)
Measured: Post-intervention (12 weeks)
Changes in peripheral muscle strength
Changes in handgrip and quadriceps muscles strength (higher scores mean better outcome)
Measured: Post-intervention (12 weeks)
Changes in respiratory muscle strength
Changes in maximal inspiratory and expiratory muscle strength (higher scores mean better outcome)
Measured: Post-intervention (12 weeks)
Changes in physical activity
Changes in physical activity assessed by activity monitors (higher scores mean better outcome)
Measured: Post-intervention (12 weeks)
Attendance
Attended sessions (0-100%, patients are expected to attend a minimum of 80% sessions)
Measured: Post-intervention (12 weeks)
Exercise tolerability
Patients not requiring exercise discontinuation or intensity modification
Measured: Post-intervention (12 weeks)
Changes in muscle mass
Changes in muscle mass assessed with total body dual energy X-ray
Measured: 1 month post-KT
Changes in mood state
Changes in Hospital Anxiety Depression Scale
Measured: Through study completion, an average of 1 year
Changes in health-related quality of life
Score in the Short-Form 36 questionnaire (8 dimensions scoring 0-100, higher scores mean better outcomes)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Model description
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Pascual Santos, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701398
- Sponsor's protocol ID
- PI19/0037
- Acronym
- Frailmar
- Status last verified
- May 2023
- First submitted
- 5 Jan 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Saez MJ, Munoz-Redondo E, Morgado-Perez A, Delcros-Forestier L, Bach A, Faura A, Redondo D, Chamoun B, Burballa C, Buxeda A, Crespo M, Marco E, Pascual J; FRAILMar Study Group. Exercise-Based Prehabilitation for Kidney Transplant Candidates: the FRAILMar Randomized Controlled Trial. Am J Kidney Dis. 2025 Nov;86(5):634-645.e1. doi: 10.1053/j.ajkd.2025.07.003. Epub 2025 Aug 13.
PubMed 40816623Perez-Saez MJ, Morgado-Perez A, Faura A, Munoz-Redondo E, Garriz M, Muns MD, Nogues X, Marco E, Pascual J. The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. Front Med (Lausanne). 2021 May 19;8:675049. doi: 10.3389/fmed.2021.675049. eCollection 2021.
PubMed 34095178
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Patients With Advanced Chronic Kidney Disease Waiting for a Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.
- ClinicalTrials.gov ID
- NCT04701398
- Acronym / sponsor ID
- Frailmar / PI19/0037
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, kidney transplantation, frailty, prehabilitation, exercise, nutritional status, psychological advice, sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jan 2021 (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.
Frailty is very frequent among patients waiting for a kidney transplantation (KT). Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Frailty in patients with chronic kidney disease (CKD) displays a constellation of features that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. A pre-transplant intervention including physical therapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.
The main objective is to assess effectiveness, feasibility and safety of a prehabilitation program (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates on clinical and functional outcomes after KT.
Detailed description
Frailty is very frequent among patients with chronic kidney disease (CKD) included in the waiting list for deceased donor kidney transplantation (KT), and outcomes are worsened in those frail recipients after KT. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcareutilization after KT. Frailty in CKD patients displays a unique constellation of features such as muscle wasting, anorexia, protein energy wasting, inflammation, oxidative stress, catabolic/anabolic hormone imbalance, metabolic acidosis, and other cellularalterations that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. Efforts to intervene with post- transplant physical therapy have been met with limited success, in large part due to high study dropout. A pre-transplant clinical framework for multimodal prehabilitation interventions including physicaltherapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention andcompliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.
The main objective of this study is to assess effectiveness, feasibility and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates in the context of a randomized controlled clinical trial. The primary endpoint will be a composite achievement of clinical and functional outcomes in frail and non-frail KT candidates after KT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Multimodal intervention | Experimental | Other: Multimodal prehabilitationsupervised physical training (1-hour sessions, 24 sessions, 8 weeks) + nutritional supplementation + psychological advice |
| Standard Care | No intervention | –Healthy living recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults patients with chronic kidney disease
- Inclusion in the waiting list for deceased donor kidney transplantation in the period September 2020 to August 2022
Key exclusion criteria (1 listed)
- Patients unable to perform the exercise plan or giving informed consent
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 |
|---|---|---|
| Multimodal prehabilitationExercise + nutritional supplementation + psychological advice | Other | Multimodal intervention |
Primary outcome
Bad-Outcome Composite Endpoint
Time frame: 90 days post-kidney transplantation
Delayed draft function >14 days + never functioning kidney + non-elective readmission before day 90 + surgical complications (wound healing problems, obstructive lymphocele, vascular thrombosis, urinary stenosis or leak, acute hemorrhage, immediate re-intervention) + discharge to an assisted facility + all-cause death.
9 secondary outcomes
Changes in exercise capacity
Time frame: Post-intervention (12 weeks)
Changes in peripheral muscle strength
Time frame: Post-intervention (12 weeks)
Changes in respiratory muscle strength
Time frame: Post-intervention (12 weeks)
Changes in physical activity
Time frame: Post-intervention (12 weeks)
Attendance
Time frame: Post-intervention (12 weeks)
Exercise tolerability
Time frame: Post-intervention (12 weeks)
Changes in muscle mass
Time frame: 1 month post-KT
Changes in mood state
Time frame: Through study completion, an average of 1 year
Changes in health-related quality of life
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 40816623Perez-Saez MJ, Munoz-Redondo E, Morgado-Perez A, Delcros-Forestier L, Bach A, Faura A, Redondo D, Chamoun B, Burballa C, Buxeda A, Crespo M, Marco E, Pascual J; FRAILMar Study Group. Exercise-Based Prehabilitation for Kidney Transplant Candidates: the FRAILMar Randomized Controlled Trial. Am J Kidney Dis. 2025 Nov;86(5):634-645.e1. doi: 10.1053/j.ajkd.2025.07.003. Epub 2025 Aug 13.
- Derived from this study: PubMed 34095178Perez-Saez MJ, Morgado-Perez A, Faura A, Munoz-Redondo E, Garriz M, Muns MD, Nogues X, Marco E, Pascual J. The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. Front Med (Lausanne). 2021 May 19;8:675049. doi: 10.3389/fmed.2021.675049. eCollection 2021.
- 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.
Julio Pascual Santos principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation in people with Chronic Kidney Diseases, run by Parc de Salut Mar 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 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ester Marco, MD (+34699706860, emarco@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bad-Outcome Composite Endpoint (time frame: 90 days post-kidney transplantation). 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 NCT04701398, which also lists 2 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 18 Nov 2023.