Cancer SurvivorsNCT06853613
Comparing Multicomponent and Aerobic Training: Impact on Fitness, Psychological and Quality of Life Parameters in Cancer Survivors Patients
A study testing Multicomponent Training Protocol and Aerobic Training Protocol in people with Cancer Survivors, run by University of Bari Aldo Moro at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an aerobic training program (AT) can improve physiological, physical fitness, mental well-being, and quality of life in cancer survivors currently stabilized. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Multicomponent Training Protocol and Aerobic Training Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to 30 Jun 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women/Men;
- Age between 18 and 80 years at the time of initial treatment;
- Subjects in remission for at least 3 months;
- No diagnosis of secondary cancer at baseline;
- No physical impediment to physical activity (Eastern Cooperative Oncology Groups (ECOG) performance status 0-1);
- Signature of a written informed consent form (or their legally recognized representatives must sign) indicating that the patient understood the purpose and procedures required for the study and is willing to participate in the study;
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- Sedentary lifestyle (subjects who have not followed WHO guidelines for aerobic and resistance exercise in the past 3 months).
- Currently in treatment, as long as not hospitalized, in stabilized chronic condition,
- Positive medical specialist assessment of noncompetitive physical activity practice.
Who cannot join
- Metastasis;
- Uncontrolled hypertension or untreated heart disease;
- Severe musculoskeletal or joint disorders with severe mobility limitations;
- Psychiatric disorders;
- Taking psychotropic drugs;
- Inability to engage in physical activity;
- Lack of fitness to practice sports.
- Expected absence of more than two weeks during the intervention period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Adapted Multicomponent Training Program (Adapted Physical and Sports Activity - AFA) for Promoting Mental and Physical Well-being in Cancer Survivors Currently in Physiological or Chronic-stabilized Condition
The goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an aerobic training program (AT) can improve physiological, physical fitness, mental well-being, and quality of life in cancer survivors currently stabilized. The main questions it aims to answer are:
Does MCT or AT improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does MCT provide superior physiological an psychological improvements compared to AT?
Read more
Researchers will compare:
MCT (a combination of aerobic, mobility, and resistance training exercises) AT (an aerobic-solo training) to see if these interventions improve fitness, health, psychological and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant differences between MCT and AT .
Participants will:
Complete assessments of anthropometric, physical fitness, and psychological parameters at baseline (T0) and after 24 weeks (T1).
Be randomly assigned to one of three groups (MCT, AT, or WLCG).
Engage in a 24-week structured training program (MCT or IMCT) supervised by exercise professionals, including:
Warm-up sessions (10 minutes, low-intensity walking). Main sessions (40 minutes): aerobic, mobility, resistance (MCT), only-aerobic (AT) exercises.
Cool-down sessions (10 minutes): breathing and stretching exercises.
This study will provide insights into the efficacy of tailored physical activity interventions for stabilized Cancer survivors.
- Conditions
- Cancer Survivors
- Being tested
- Multicomponent Training Protocol, Aerobic Training Protocol
- Keywords
- cancer-related fatigue, mental and physical well-being, muscle function, anxiety-depressive symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Training ProtocolOther
Each session consists of:
Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.
Main phase (40 minutes):
Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.
Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).
Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).
Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).
Aerobic Training ProtocolOther
Each training session will include an initial 10-minute muscle activation phase (low-intensity walking, Borg = 10-11) to increase heart rate, improve muscle blood flow, and prepare the major joints for the next work phase.
main exercise period (40-minute):
25 minutes of progressive aerobic exercises (controlled and rhythmic jumping jacks, step-ups on a sturdy platform (such as a low step or stable surface), standing knee raises (alternating legs), fast side steps or side leg raises).
15 minutes of walking, exercises will be performed at an intensity to ensure that perceived exertion (RPE) will remain between 13 and 15 points on the Borg Scale (6-20). Progression over the weeks will be by maintaining intensity in this range.
Cool down period: breathing and stretching exercises on all major muscle groups.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Training (MCT) | Experimental | subjects assigned to the MCT group will perform a training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components. Receives: Other: Multicomponent Training Protocol |
| Aerobic training (AT) | Experimental | subjects assigned to the AT group will perform training protocol of only aerobic exercises. Receives: Other: Aerobic Training Protocol |
| Waiting List Control Group (WLCG) | No intervention | Subjects assigned to the WLCG group will not engage in any structured physical activity throughout the intervention period, continuing with their usual lifestyle, and will be placed on a waiting list, ensuring their participation in adapted physical activity at the end of the 24-week intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body body fat percentage
Body fat percentage assessed throught the Bioelectrical Impedance Analysis (BIA):
Body fat percentage (in %)
The procedure involves sending a low-level electrical current through the body and measuring resistance.
Interpretation:
Higher body fat percentage indicates more fat.
Measured: 24-weeks
Change in Body Water
Body water content assessed throught the Bioelectrical Impedance Analysis (BIA):
Total body water (in %)
The procedure involves sending a low-level electrical current through the body and measuring resistance.
Interpretation:
Higher total body water suggests better hydration.
Measured: 24-weeks
Change in Muscle Mass
muscle mass assessed throught the Bioelectrical Impedance Analysis (BIA):
Muscle mass (in kg)
The procedure involves sending a low-level electrical current through the body and measuring resistance.
Interpretation:
Higher muscle mass suggests better muscle development.
Measured: 24-weeks
Change in lower body strength
30-s chair stand (30CST) test: Sit-to-stand from a chair during 30 seconds (measured in seconds)
Measured: 24-weeks
Change in functional mobility
Timed Up and Go (TUG) Test (measured in seconds)
Measured: 24-weeks
Change in Handrigp Strength
Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf)
Measured: 24-weeks
Change in aerobic capacity
2-Minute Step Test (TMST): march in place for 2 minutes, lifting their knees to a height halfway between the iliac crest and the patella.The number of full knee lifts (repetitions) completed in 2 minutes is recorded.
Measured: 24-weeks
Change in lower body flexibility
Chair Sit-and-Reach Test: measures lower body flexibility (hamstrings and lower back) in centimeters (cm). It involves sitting on a chair, extending one leg, and reaching toward the toes to assess mobility. The measurement is taken by recording the distance between the fingertips and the toes. Positive score (+): Fingertips go past the toes.Zero score (0): Fingertips touch the toes. Negative score (-): Fingertips fall short of the toes.
A ruler or tape measure is used to record the exact distance.
Measured: 24-weeks
Change in upper body flexibility
Back Scratch Test: measures upper body flexibility, particularly shoulder mobility, in centimeters (cm). It involves reaching one hand over the shoulder and the other behind the back to touch or overlap fingers.
Positive score (+): Fingers overlap (measured as the overlap distance). Zero score (0): Fingers just touch. Negative score (-): Fingers do not touch (measured as the gap distance).
A ruler or tape measure is used to record the exact distance.
Measured: 24-weeks
Change in psychological parameters (anxiety).
State-Trait Anxiety Inventory (STAI-Y): measures anxiety levels using a numerical score. It consists of 20 items assessing temporary (state) anxiety on a 4-point scale (1 = not at all to 4 = very much so).
Total score range: 20 to 80 (higher scores indicate greater anxiety).
Interpretation:
20-37: Low anxiety 38-44: Moderate anxiety 45-80: High anxiety
The final score is obtained by summing the responses.
Measured: 24-weeks
Change in psychological parameters (depression).
Beck Depression Inventory (BDI): measures depression severity using a numerical score. It consists of 21 items, each rated on a 4-point scale (0 to 3) based on symptom severity.
Total score range: 0 to 63 (higher scores indicate more severe depression).
Interpretation:
0-13: Minimal depression 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression
The final score is obtained by summing the responses.
Measured: 24-weeks
Change in psychological parameters (Fatigue).
Fatigue Severity Scale (FSS): measures the impact of fatigue on daily life using a numerical score. It consists of 9 items, each rated on a 7-point scale (1 = strongly disagree to 7 = strongly agree).
Total score range: 9 to 63 (higher scores indicate greater fatigue severity).
Interpretation:
- 36: Low to moderate fatigue >36: High fatigue
The final score is the average of all 9 responses.
Measured: 24-weeks
Change in psychological parameters (Quality of Life).
EORTC QLQ-C30: assesses the quality of life in cancer patients using a numerical score. It consists of 30 questions covering functional status, symptoms, and overall health, rated on a 4-point scale (1 = not at all to 4 = very much) or a 7-point scale (1 = very poor to 7 = excellent).
Scores range from 0 to 100 (higher scores indicate better functioning for global health/function scales and worse symptoms for symptom scales).
Interpretation:
Functional scales: Higher scores = better function. Symptom scales: Higher scores = more severe symptoms.
Scores are calculated and standardized based on EORTC guidelines.
Measured: 24-weeks
Change in psychological parameters (Coping).
Brief COPE: assesses coping strategies using a numerical score. It consists of 28 items, grouped into 14 coping strategies, each rated on a 4-point scale (1 = I haven't been doing this at all to 4 = I've been doing this a lot).
Scores range from 2 to 8 per coping strategy (higher scores indicate greater use of that coping strategy).
Interpretation:
Higher scores in adaptive strategies (e.g., active coping, planning) suggest positive coping.
Higher scores in maladaptive strategies (e.g., denial, self-blame) may indicate ineffective coping.
Final scores are analyzed per strategy rather than as a total score.
Measured: 24-weeks
Secondary outcomes (1)
Evaluation of adherence to training protocols
Adherence (%): (Number of prescribed activities/Number of completed activities )×100
Measured: 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start8 Jan 2025
- Primary completion31 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Poli, University of Bari Aldo Moro
- Investigators
- Luca Poli, Dr., Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853613
- Sponsor's protocol ID
- 0324886
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Adapted Multicomponent Training Program (Adapted Physical and Sports Activity - AFA) for Promoting Mental and Physical Well-being in Cancer Survivors Currently in Physiological or Chronic-stabilized Condition
- ClinicalTrials.gov ID
- NCT06853613
- Acronym / sponsor ID
- 0324886
- Conditions
- Cancer Survivors
- Keywords
- cancer-related fatigue, mental and physical well-being, muscle function, anxiety-depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 3 Mar 2025 (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 goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an aerobic training program (AT) can improve physiological, physical fitness, mental well-being, and quality of life in cancer survivors currently stabilized. The main questions it aims to answer are:
Does MCT or AT improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does MCT provide superior physiological an psychological improvements compared to AT?
Researchers will compare:
MCT (a combination of aerobic, mobility, and resistance training exercises) AT (an aerobic-solo training) to see if these interventions improve fitness, health, psychological and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant differences between MCT and AT .
Participants will:
Complete assessments of anthropometric, physical fitness, and psychological parameters at baseline (T0) and after 24 weeks (T1).
Be randomly assigned to one of three groups (MCT, AT, or WLCG).
Engage in a 24-week structured training program (MCT or IMCT) supervised by exercise professionals, including:
Warm-up sessions (10 minutes, low-intensity walking). Main sessions (40 minutes): aerobic, mobility, resistance (MCT), only-aerobic (AT) exercises.
Cool-down sessions (10 minutes): breathing and stretching exercises.
This study will provide insights into the efficacy of tailored physical activity interventions for stabilized Cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Training (MCT) | Experimental | Other: Multicomponent Training Protocolsubjects assigned to the MCT group will perform a training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components. |
| Aerobic training (AT) | Experimental | Other: Aerobic Training Protocolsubjects assigned to the AT group will perform training protocol of only aerobic exercises. |
| Waiting List Control Group (WLCG) | No intervention | –Subjects assigned to the WLCG group will not engage in any structured physical activity throughout the intervention period, continuing with their usual lifestyle, and will be placed on a waiting list, ensuring their participation in adapted physical activity at the end of the 24-week intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women/Men;
- Age between 18 and 80 years at the time of initial treatment;
- Subjects in remission for at least 3 months;
- No diagnosis of secondary cancer at baseline;
- No physical impediment to physical activity (Eastern Cooperative Oncology Groups (ECOG) performance status 0-1);
Key exclusion criteria (8 listed)
- Metastasis;
- Uncontrolled hypertension or untreated heart disease;
- Severe musculoskeletal or joint disorders with severe mobility limitations;
- Psychiatric disorders;
- Taking psychotropic drugs;
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 |
|---|---|---|
| Multicomponent Training ProtocolEach session consists of: Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints. Main phase (40 minutes): Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts. Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise). Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15). Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch). | Other | Multicomponent Training (MCT) |
| Aerobic Training ProtocolEach training session will include an initial 10-minute muscle activation phase (low-intensity walking, Borg = 10-11) to increase heart rate, improve muscle blood flow, and prepare the major joints for the next work phase. main exercise period (40-minute): 25 minutes of progressive aerobic exercises (controlled and rhythmic jumping jacks, step-ups on a sturdy platform (such as a low step or stable surface), standing knee raises (alternating legs), fast side steps or side leg raises). 15 minutes of walking, exercises will be performed at an intensity to ensure that perceived exertion (RPE) will remain between 13 and 15 points on the Borg Scale (6-20). Progression over the weeks will be by maintaining intensity in this range. Cool down period: breathing and stretching exercises on all major muscle groups. | Other | Aerobic training (AT) |
Primary outcome
Change in Body body fat percentage
Time frame: 24-weeks
Body fat percentage assessed throught the Bioelectrical Impedance Analysis (BIA): Body fat percentage (in %) The procedure involves sending a low-level electrical current through the body and measuring resistance. Interpretation: Higher body fat percentage indicates more fat.
Change in Body Water
Time frame: 24-weeks
Body water content assessed throught the Bioelectrical Impedance Analysis (BIA): Total body water (in %) The procedure involves sending a low-level electrical current through the body and measuring resistance. Interpretation: Higher total body water suggests better hydration.
Change in Muscle Mass
Time frame: 24-weeks
muscle mass assessed throught the Bioelectrical Impedance Analysis (BIA): Muscle mass (in kg) The procedure involves sending a low-level electrical current through the body and measuring resistance. Interpretation: Higher muscle mass suggests better muscle development.
Change in lower body strength
Time frame: 24-weeks
30-s chair stand (30CST) test: Sit-to-stand from a chair during 30 seconds (measured in seconds)
Change in functional mobility
Time frame: 24-weeks
Timed Up and Go (TUG) Test (measured in seconds)
Change in Handrigp Strength
Time frame: 24-weeks
Handgrip Strength (HGS) test: muscle strength measured with manual dynamometers (Kgf)
Change in aerobic capacity
Time frame: 24-weeks
2-Minute Step Test (TMST): march in place for 2 minutes, lifting their knees to a height halfway between the iliac crest and the patella.The number of full knee lifts (repetitions) completed in 2 minutes is recorded.
Change in lower body flexibility
Time frame: 24-weeks
Chair Sit-and-Reach Test: measures lower body flexibility (hamstrings and lower back) in centimeters (cm). It involves sitting on a chair, extending one leg, and reaching toward the toes to assess mobility. The measurement is taken by recording the distance between the fingertips and the toes. Positive score (+): Fingertips go past the toes.Zero score (0): Fingertips touch the toes. Negative score (-): Fingertips fall short of the toes. A ruler or tape measure is used to record the exact distance.
Change in upper body flexibility
Time frame: 24-weeks
Back Scratch Test: measures upper body flexibility, particularly shoulder mobility, in centimeters (cm). It involves reaching one hand over the shoulder and the other behind the back to touch or overlap fingers. Positive score (+): Fingers overlap (measured as the overlap distance). Zero score (0): Fingers just touch. Negative score (-): Fingers do not touch (measured as the gap distance). A ruler or tape measure is used to record the exact distance.
Change in psychological parameters (anxiety).
Time frame: 24-weeks
State-Trait Anxiety Inventory (STAI-Y): measures anxiety levels using a numerical score. It consists of 20 items assessing temporary (state) anxiety on a 4-point scale (1 = not at all to 4 = very much so). Total score range: 20 to 80 (higher scores indicate greater anxiety). Interpretation: 20-37: Low anxiety 38-44: Moderate anxiety 45-80: High anxiety The final score is obtained by summing the responses.
Change in psychological parameters (depression).
Time frame: 24-weeks
Beck Depression Inventory (BDI): measures depression severity using a numerical score. It consists of 21 items, each rated on a 4-point scale (0 to 3) based on symptom severity. Total score range: 0 to 63 (higher scores indicate more severe depression). Interpretation: 0-13: Minimal depression 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression The final score is obtained by summing the responses.
Change in psychological parameters (Fatigue).
Time frame: 24-weeks
Fatigue Severity Scale (FSS): measures the impact of fatigue on daily life using a numerical score. It consists of 9 items, each rated on a 7-point scale (1 = strongly disagree to 7 = strongly agree). Total score range: 9 to 63 (higher scores indicate greater fatigue severity). Interpretation: * 36: Low to moderate fatigue >36: High fatigue The final score is the average of all 9 responses.
Change in psychological parameters (Quality of Life).
Time frame: 24-weeks
EORTC QLQ-C30: assesses the quality of life in cancer patients using a numerical score. It consists of 30 questions covering functional status, symptoms, and overall health, rated on a 4-point scale (1 = not at all to 4 = very much) or a 7-point scale (1 = very poor to 7 = excellent). Scores range from 0 to 100 (higher scores indicate better functioning for global health/function scales and worse symptoms for symptom scales). Interpretation: Functional scales: Higher scores = better function. Symptom scales: Higher scores = more severe symptoms. Scores are calculated and standardized based on EORTC guidelines.
Change in psychological parameters (Coping).
Time frame: 24-weeks
Brief COPE: assesses coping strategies using a numerical score. It consists of 28 items, grouped into 14 coping strategies, each rated on a 4-point scale (1 = I haven't been doing this at all to 4 = I've been doing this a lot). Scores range from 2 to 8 per coping strategy (higher scores indicate greater use of that coping strategy). Interpretation: Higher scores in adaptive strategies (e.g., active coping, planning) suggest positive coping. Higher scores in maladaptive strategies (e.g., denial, self-blame) may indicate ineffective coping. Final scores are analyzed per strategy rather than as a total score.
1 secondary outcome
Evaluation of adherence to training protocols
Time frame: 24-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- 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.
Luca Poli, Dr. principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Training Protocol and Aerobic Training Protocol in people with Cancer Survivors, run by University of Bari Aldo Moro at 1 site in Italy.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 3 Jul 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Body body fat percentage (time frame: 24-weeks). The study lists 14 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 Jul 2025.