Graft Vs Host DiseaseIRENE-GNCT05111834
IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
A study testing Supervised resistance training plus nutritional endorsement and Nutritional endorsement in people with Graft Vs Host Disease, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The IRENE-G trial is a randomized controlled study that aims to investigate the effect of a supervised resistance exercise program (2x/week for 24 weeks) in combination with a nutritional intervention on physical performance/frailty in patients with GvHD symptoms treated with high dose steroids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Vs Host Disease
- What is being tested?
- Supervised resistance training plus nutritional endorsement and Nutritional endorsement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2021to 30 Nov 2025
- 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
- Existing or new diagnosis of acute or chronic GvHD treated with systemic steroid therapy (≥0,5 mg/kg/day)
- Sufficient German language skills
- Willing/ able to train at the provided exercise facilities or online twice a week
- Willing/ able to take part in the scheduled testing
- Capacity to consent
- Signed informed consent
Who cannot join
- Any physical or mental conditions that would hamper the adherence to the training and/or nutritional program or the completion of the study procedures
- Heart insufficiency > NYHA III or uncertain arrhythmia
- Uncontrolled hypertension
- Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
- Reduced standing or walking ability
- Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL)
- Any other comorbidities that preclude participation in the exercise programs
Trial locations and contacts
1 site in 1 country.
About this study
The IRENE-G trial is a randomized controlled study that aims to investigate the effect of a supervised resistance exercise program (2x/week for 24 weeks) in combination with a nutritional intervention on physical performance/frailty in patients with GvHD symptoms treated with high dose steroids.
Read the detailed description
Graft-versus-host disease (GvHD) remains the major complication and limitation to successful allogeneic hematopoietic stem cell transplantation (allo-HSCT). Treatment of GvHD is challenging, with high-dose steroids remaining the established first-line treatment in both acute and chronic GvHD. Long-term doses of systemic corticosteroids have many well-known side-effects such as myopathy, though often an overlooked diagnosis. Previous studies in non-cancer patients treated with corticosteroids demonstrated that resistance training can reverse muscle atrophy and weakness. Despite the beneficial effects of exercise, no research effort to date has explicitly examined the effect of a progressive moderate-to-high intensity resistance training on the physical performance and well-being of GvHD patients treated with high-dose steroids. As GvHD patients are commonly found to be malnourished, which affects muscle mass and strength and thus quality of life, nutritional endorsement and optimization should be considered when investigating the effect of exercise in GvHD patients.
The IRENE-G study (acronym for Impact of Resistance Exercise and Nutritional Endorsement on GvHD symptoms) is a 24 week prospective, randomized controlled intervention trial with a two-armed parallel design and 1:1 allocation ratio of GvHD patients treated with high-dose steroids.The exploratory study examines and compares the effects of a supervised resistance exercise intervention - 2x per week, 60 minutes - and a nutritional optimisation program (experimental group) against a nutritional optimisation program only (control group) on physical performance in GvHD patients treated with high-dose steroids. We hypothesize that patients in the experimental group will show significantly greater improvements (or an attenuated decrement) in their physical performance after 24-weeks compared to the control group. Moreover, the investigators hypothesized that the experimental group will have lower levels of fatigue, a higher perceived quality of life, better muscle strength values and a higher vastus lateralis muscle volume, a better nutritional status as well as a better submaximal endurance capacity compared to the control group.
On the basis of power calculations, the goal is to include 56 patients per intervention arm, resulting in a total patient number of n=112.
Assessments will take place at week 8, 16 and 24 after baseline. A follow-up assessment is planned at week 48.
The primary outcome of IRENE-G is physical performance measured via the Short Physical Performance Battery. Further endpoints are muscle strength and volume, submaximal endurance capacity, nutritional status and patient-reported outcomes such as quality of life and fatigue.
- Conditions
- Graft Vs Host Disease
- Being tested
- Supervised resistance training plus nutritional endorsement, Nutritional endorsement
- Keywords
- Resistance Training, Nutritional Endorsement, Allogenic stem cell transplantation, Steroid-induced myopathy, Cancer, Exercise, Graft versus host disease, Physical performance
- Medical subject headings
- Graft vs Host Disease, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised resistance training plus nutritional endorsementBehavioural
resistance training 2x per week, nutritional endorsement/therapy based on individual needs
Nutritional endorsementBehavioural
nutritional endorsement/therapy based on individual needs
| Study group | Role | What they receive |
|---|---|---|
| Supervised resistance training plus nutritional endorsement | Experimental | The study participants receive a progressive moderate-to-high-intensity resistance training program (a 60 minutes twice a week for a period of 24- weeks) plus nutritional endorsement. The training will take place at the NCT Heidelberg, in regional qualified facility centers or online under supervision and guidance of experienced exercise therapists.
The progressive resistance program for participants who train at facility centers comprises of 6 machine-based exercises, each performed 2 sets,12 repetitions of 60%-80% of 1 RM. For participants who train online, the training load will be defined during the introductory training session with the aim of choosing a load which to perform two times 12 repetitions. The program targets major upper and lower body muscle groups (with emphasis on the lower extremities). In addition, patients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition. Receives: Behavioral: Supervised resistance training plus nutritional endorsement |
| Nutritional endorsement only | Active comparator | Patients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition. Receives: Behavioral: Nutritional endorsement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB)
Physical Performance will be assessed with the Short Physical Performance Battery (SPPB). The SPPB is based on three timed tasks: 4-meter walking speed test, standing balance (feet side-by-side, semi-tandem, full tandem) and sit-to-stand test. Participants score on each component of the battery. Each task is scored out of 4. The sum of the three assessments comprised the final SPPB score with a possible range from 0 to 12. A higher score represents a higher level of function, while lower level indicate lower level of function. Change = (Week 24 Score - Baseline Score). The SPPB is a well-established instrument for the measurement of physical performance, commonly used is elderly patients both in hospital and community setting.
Measured: up to 24 weeks (& 6 month follow-up)
Secondary outcomes (9)
Change from baseline to week 24 in Submaximal endurance performance, assessed with the 6 minute walk test
The 6 minute walk test will be used to determine the submaximal endurance capacity. The test measures the distance an individual is able to walk over a total of six minutes. The goal is for the individual to walk as far as possible within six minutes.
Measured: up to 24 weeks (& 6 month follow-up)
Change from baseline to week 24 in Muscle strength performance, as measured by Hand-held dynamometer
A hand-held dynamometer will be applied to assess maximal voluntary isometric muscle contraction in Newton meters in 6 muscle groups (knee and elbow flexors and extensors, hip flexors and abductors). Muscle groups will be assessed bilaterally for their isometric power. Change = (Week 24 value - Baseline value)
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Muscle volume, assessed with ultrasound measurement
Ultrasound measurement will be performed to determine the thickness and cross sectional area of both vastus lateralis muscles as well as subcutaneous adipose tissue thickness. Change = (Week 24 value - Baseline value)
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Nutritional Status
The nutritional status will be determined using the Nutritional Risk Screening (NRS 2002), lab parameters (e.g. albumin and total protein), hand-grip strength.
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 Health related Quality of life, as measured by the EORTC QLQ-C30
Quality of life will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symtom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 24 Score - Baseline Score)
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in high-dose chemotherapy and stem cell transplantation-related symptoms and problems, as measured by the EORTC QLQ-HDC 29
The EORTC QLQ-HDC 29 is a 29-item quality of life questionnaire, which has been developed to elicit patient's experience of symptoms and problems during and after high-dose chemotherapy and stem cell transplantation (57). It consists of 6 multi-item scales (gastro-intestinal side-effects, worry/anxiety, impact on family, body image, sexuality, in-patient issues) and 8 single-item (skin problems, fever/chills, urinary frequency, aches or pain in bones, taking regular drugs, finishing things, ability to have children, experience helping to distinguish what is important in life) questions. Scores range from 0 to 100 with higher score representing higher levels of problems. Change = (Week 24 Score - Baseline Score)
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Cancer-related Fatigue, as measured by the EORTC QLQ-FA12
Fatigue will be assessed via the EORTC QLQ-FA 12 questionnaire, which is an internationally validated phase IV module of the European Organisation for Research and Treatment of Cancer. The module assesses physical, cognitive and emotional aspects of cancer-related fatigue. It is composed of 12 questions, 10 unidirectional and 2 criteria variables which measure the extent to which fatigue interferes with daily activities and social life. Scores range from 0 to 100. Higher scores represent a higher level of fatigue symptomatology. Change = (Week 24 Score - Baseline Score)
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in patient-perceived GVHD symptom bother, as measured by the modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
The modified 7-day Lee Chronic-versus-Host Disease Symptom Scale will be used to capture the GvHD-specific symptom burden. It is a 28 item, 7-domain symptom scale (skin, eyes, mouth, lung, nutrition, energy and psych). Patients will report their level of symptom bother over a period of 7 days on a 5-point Likert scale.
Measured: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Functional Status determined with the Karnofsky performance scale
The Karnofsky performance scale (KPS) will be applied to assess functional status of a patient. The KPS is a 11-point rating scale, which ranges from normal functioning (100%) to dead (0%). The scale is widely used due to its psychometric properties and recommended in clinical assessments.
Measured: up to week 24 (& 6 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start15 Sep 2021
- Primary completion31 May 2025 (estimated)
- Study completion30 Nov 2025 (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 Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
- Investigators
- Joachim Wiskemann, PD Dr., Principal investigator, Heidelberg University Hospital, National center for Tumor Diseases, Division of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111834
- Sponsor's protocol ID
- DJCLS 12R/2019
- Acronym
- IRENE-G
- Status last verified
- Jan 2025
- First submitted
- 29 Sep 2021
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939Bujan Rivera J, Kuhl R, Zech U, Hendricks A, Luft T, Dreger P, Friedmann-Bette B, Betz TM, Wiskemann J. Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) - design and rational of a randomized controlled trial. BMC Cancer. 2022 Apr 22;22(1):440. doi: 10.1186/s12885-022-09497-1.
PubMed 35459108
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
- ClinicalTrials.gov ID
- NCT05111834
- Acronym / sponsor ID
- IRENE-G / DJCLS 12R/2019
- Conditions
- Graft Vs Host Disease
- Keywords
- Resistance Training, Nutritional Endorsement, Allogenic stem cell transplantation, Steroid-induced myopathy, Cancer, Exercise, Graft versus host disease, Physical performance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Nov 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.
The IRENE-G trial is a randomized controlled study that aims to investigate the effect of a supervised resistance exercise program (2x/week for 24 weeks) in combination with a nutritional intervention on physical performance/frailty in patients with GvHD symptoms treated with high dose steroids.
Detailed description
Graft-versus-host disease (GvHD) remains the major complication and limitation to successful allogeneic hematopoietic stem cell transplantation (allo-HSCT). Treatment of GvHD is challenging, with high-dose steroids remaining the established first-line treatment in both acute and chronic GvHD. Long-term doses of systemic corticosteroids have many well-known side-effects such as myopathy, though often an overlooked diagnosis. Previous studies in non-cancer patients treated with corticosteroids demonstrated that resistance training can reverse muscle atrophy and weakness. Despite the beneficial effects of exercise, no research effort to date has explicitly examined the effect of a progressive moderate-to-high intensity resistance training on the physical performance and well-being of GvHD patients treated with high-dose steroids. As GvHD patients are commonly found to be malnourished, which affects muscle mass and strength and thus quality of life, nutritional endorsement and optimization should be considered when investigating the effect of exercise in GvHD patients.
The IRENE-G study (acronym for Impact of Resistance Exercise and Nutritional Endorsement on GvHD symptoms) is a 24 week prospective, randomized controlled intervention trial with a two-armed parallel design and 1:1 allocation ratio of GvHD patients treated with high-dose steroids.The exploratory study examines and compares the effects of a supervised resistance exercise intervention - 2x per week, 60 minutes - and a nutritional optimisation program (experimental group) against a nutritional optimisation program only (control group) on physical performance in GvHD patients treated with high-dose steroids. We hypothesize that patients in the experimental group will show significantly greater improvements (or an attenuated decrement) in their physical performance after 24-weeks compared to the control group. Moreover, the investigators hypothesized that the experimental group will have lower levels of fatigue, a higher perceived quality of life, better muscle strength values and a higher vastus lateralis muscle volume, a better nutritional status as well as a better submaximal endurance capacity compared to the control group.
On the basis of power calculations, the goal is to include 56 patients per intervention arm, resulting in a total patient number of n=112.
Assessments will take place at week 8, 16 and 24 after baseline. A follow-up assessment is planned at week 48.
The primary outcome of IRENE-G is physical performance measured via the Short Physical Performance Battery. Further endpoints are muscle strength and volume, submaximal endurance capacity, nutritional status and patient-reported outcomes such as quality of life and fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised resistance training plus nutritional endorsement | Experimental | Behavioral: Supervised resistance training plus nutritional endorsementThe study participants receive a progressive moderate-to-high-intensity resistance training program (a 60 minutes twice a week for a period of 24- weeks) plus nutritional endorsement. The training will take place at the NCT Heidelberg, in regional qualified facility centers or online under supervision and guidance of experienced exercise therapists. The progressive resistance program for participants who train at facility centers comprises of 6 machine-based exercises, each performed 2 sets,12 repetitions of 60%-80% of 1 RM. For participants who train online, the training load will be defined during the introductory training session with the aim of choosing a load which to perform two times 12 repetitions. The program targets major upper and lower body muscle groups (with emphasis on the lower extremities). In addition, patients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition. |
| Nutritional endorsement only | Active comparator | Behavioral: Nutritional endorsementPatients receive nutritional advice/diet modification, depending on their individual requirements and/or changes in general condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Existing or new diagnosis of acute or chronic GvHD treated with systemic steroid therapy (≥0,5 mg/kg/day)
- Sufficient German language skills
- Willing/ able to train at the provided exercise facilities or online twice a week
- Willing/ able to take part in the scheduled testing
- Capacity to consent
Key exclusion criteria (7 listed)
- Any physical or mental conditions that would hamper the adherence to the training and/or nutritional program or the completion of the study procedures
- Heart insufficiency > NYHA III or uncertain arrhythmia
- Uncontrolled hypertension
- Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
- Reduced standing or walking ability
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 |
|---|---|---|
| Supervised resistance training plus nutritional endorsementresistance training 2x per week, nutritional endorsement/therapy based on individual needs | Behavioural | Supervised resistance training plus nutritional endorsement |
| Nutritional endorsementnutritional endorsement/therapy based on individual needs | Behavioural | Nutritional endorsement only |
Primary outcome
Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB)
Time frame: up to 24 weeks (& 6 month follow-up)
Physical Performance will be assessed with the Short Physical Performance Battery (SPPB). The SPPB is based on three timed tasks: 4-meter walking speed test, standing balance (feet side-by-side, semi-tandem, full tandem) and sit-to-stand test. Participants score on each component of the battery. Each task is scored out of 4. The sum of the three assessments comprised the final SPPB score with a possible range from 0 to 12. A higher score represents a higher level of function, while lower level indicate lower level of function. Change = (Week 24 Score - Baseline Score). The SPPB is a well-established instrument for the measurement of physical performance, commonly used is elderly patients both in hospital and community setting.
9 secondary outcomes
Change from baseline to week 24 in Submaximal endurance performance, assessed with the 6 minute walk test
Time frame: up to 24 weeks (& 6 month follow-up)
Change from baseline to week 24 in Muscle strength performance, as measured by Hand-held dynamometer
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Muscle volume, assessed with ultrasound measurement
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Nutritional Status
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 Health related Quality of life, as measured by the EORTC QLQ-C30
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in high-dose chemotherapy and stem cell transplantation-related symptoms and problems, as measured by the EORTC QLQ-HDC 29
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Cancer-related Fatigue, as measured by the EORTC QLQ-FA12
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in patient-perceived GVHD symptom bother, as measured by the modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
Time frame: up to week 24 (& 6 month follow-up)
Change from baseline to week 24 in Functional Status determined with the Karnofsky performance scale
Time frame: up to week 24 (& 6 month follow-up)
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 Feb 2025.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Derived from this study: PubMed 35459108Bujan Rivera J, Kuhl R, Zech U, Hendricks A, Luft T, Dreger P, Friedmann-Bette B, Betz TM, Wiskemann J. Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) - design and rational of a randomized controlled trial. BMC Cancer. 2022 Apr 22;22(1):440. doi: 10.1186/s12885-022-09497-1.
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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.
Joachim Wiskemann, PD Dr. principal investigator
Heidelberg University Hospital, National center for Tumor Diseases, Division of Medical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised resistance training plus nutritional endorsement and Nutritional endorsement in people with Graft Vs Host Disease, run by University Hospital Heidelberg at 1 site in Germany.
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 7 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 3 Feb 2025. 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 Germany. 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?
Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB) (time frame: up to 24 weeks (& 6 month follow-up)). 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 NCT05111834, 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 3 Feb 2025.