Adult DiseaseNCT04958499
Effectiveness of Bio-Healthy Park on Adult
A study testing Bio-healthy Park in people with Adult Disease, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Disease
- What is being tested?
- Bio-healthy Park
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 30 Sep 2022
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- not having participated in a structured exercise program for at least 1 year;
- being older than 50 years of age
- being physically independent.
Who cannot join
- having musculoskeletal injuries or limitations that could affect the person's health and physical performance
- being under medical prescription for taking medications that could influence physical performance
- not regularly attending the proposed sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical and Psychological Effectiveness of Bio-Healthy Park on Adult
Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance. Therefore, general objective of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and Mediterranean diet adherence in adults and older adults. The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study. It will be measure body composition, bone mineral density, blood pressure, upper limb strength, lower limb strength, functional capacity, sarcopenia, sagittal disposition of the spine, Health-related quality of life, satisfaction with life and Mediterranean diet adherence. Experimental group will receive the exercise program on bio-healthy park machine with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The control group will not perform any intervention program following their usual activity.
Read the detailed description
The aging process is associated with physiological, psychological and functional deterioration. It has been demonstrated that the practice of physical activity can prevent, slow or reduce this deterioration. Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance.
Therefore, the objectives of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks, with a frequency of 2 sessions per week on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and mediterranean diet satisfaction in adults and older adults.
The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study.
The inclusion criteria are: (a) not having participated in a structured exercise program for at least 1 year, (b) being older than 50 years of age, and (c) being physically independent. The exclusion criteria are: (a) having musculoskeletal injuries or limitations that could affect the health and physical performance of the person; (b) being under medical prescription for taking medications that could influence physical performance; (c) not regularly attending the proposed sessions.
Body composition and bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA).
Blood pressure by means of an automatic device (Colin BP 880, Inc., Tampa, FL). Strength by manual dynamometry (TKK 5401; Co., Ltd., Tokyo, Japan) and maximal isometric strength of knee extension and biceps flexion.
Functional capacity will be assessed by means of the Chari stand test, gait speed, time up and go test and Short physical performance battery (SPPB), Sarcopenia will be assessed taking into account the reference values established for muscle quality (hand grip strength and chair stand test), muscle quantity (DEXA fat-free mass) and functional competence (gait speed, time up and go test, SPPB and 400 meter walk) established by the European Consensus (EWGSOP2).
The Spinal Mouse device (Switzerland) will be used to assess the sagittal disposition of the spine (thoracic curve, lumbar curve and pelvic tilt) in standing and relaxed sitting. This technique is non-invasive.
Health-related quality of life and satisfaction with life will be assessed by means of the SF36 and The Satisfaction with Life Scale (SWL) questionnaires.
Mediterranean diet adherence will be assess with a Mediterranean diet adherence questionaire.
Experimental group 1 will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The machines used will be rider, low gemini, high gemini, walk, bottoms, flywheels circles, flywheels rotation, twin swing, surf, swing press and rowing. Intensity will be controlled by subjective perception of effort and heart rate (Polar 420). There will be a warm-up 8-10 minutes, a main part 40-45 minutes and a return to calm 5-10 minutes. The intervention programs will be developed by a graduate in Physical Activity and Sport Sciences. The load will be progressed every 2 weeks. The control group will not perform any intervention program following their usual activity.
- Conditions
- Adult Disease
- Being tested
- Bio-healthy Park
- Keywords
- Adults, Older, Physical activity, Exercise, Bio-healthy park, Training
- Medical subject headings
- Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-healthy ParkBehavioural
Experimental group will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. Experimental group 1 will perform the intervention program using machinery designed for self-loading use. The machines used will be rider, low gemini, high gemini, walk, bottoms, flywheels circles, flywheels rotation, twin swing, surf, swing press and rowing. Intensity will be controlled by subjective perception of effort and heart rate (Polar 420). There will be a warm-up 8-10 minutes, a main part 40-45 minutes and a return to calm 5-10 minutes. The intervention programs will be developed by a graduate in Physical Activity and Sport Sciences. The load will be progressed every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bio-Healthy Park | Experimental | This group is the experimental group. The intervention program consisted in the realization of the program on bio-healthy machinery. Receives: Behavioral: Bio-healthy Park |
| Control | No intervention | Adults and older assigned to the control group will not received any structured exercise programme. They will maintain their usual physical activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle quality sarcopenia
Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.
Measured: Changes from baseline to 8 weeks
Secondary outcomes (15)
Change Body composition
Body composition will be assessed by dual energy X-ray absorptiometry (DEXA). This is noninvasive technique. The result will be register in absolutes and percentages results.
Measured: Changes from baseline to 8 weeks
Change Blood pressure
Blood pressure and heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in millimeters of mercury (bood pressure) and number of pulse per minutes (heart rate).
Measured: Changes from baseline to 8 weeks
Change Chair stand test
Chair stand test measure the functional capacity. This is a easy physical test. This test measures the functionality of getting up and sitting down from a chair five times. The participant have to performance the test as faster as possible. The total time is recorded in seconds. A better time indicates better functional ability.
Measured: Changes from baseline to 8 weeks
Change Upper strength
Maximal isometric upper limb strength will be performance by maximal isometric strength of knee extension and biceps flexion with load cell. Maximal isometric lower limb will be registered in newton. Higher value show high strength.
Measured: Changes from baseline to 8 weeks
Change Sagittal spinal curvature
Sagittal spinal curvature will be assess with the Spinal Mouse device (Switzerland). It will be measured: angle of the dorsal and lumbar curve and pelvic tilt when standing and in asthenic sitting. This is noninvasive technique. The result is register in grades.
Measured: Changes from baseline to 8 weeks
Health-related quality
Health-related quality of life will be assessed by means of the Short Form 36 questionaire. This questionaire have 11 questions and show result for 9 area: physical role, pain, general health, vitality, social function, emotional role, mental health, and evolution of the health care system. Each area is reported from 0 to 100 point. Higher score represent better health-related quality.
Measured: Changes from baseline to 8 weeks
Satisfaction with Life Scale (SWL)
Satisfaction with Life Scale (SWL) questionnaires include 5 affirmation about the satisfaction with the life and the participant have to answers from strongly agree to strongly disagree. The final score is reported from 5 to 35 point. Higher value show better satisfaction with life.
Measured: Changes from baseline to 8 weeks
Adherence to the Mediterranean diet
It will be used the Adherence to the Mediterranean diet. This questionaire have 14 questions (yes and no answer) about their adherence to the mediterranean diet. The sum of the answers are collect. Higher score show higher adherence to mediterranean diet.
Measured: Changes from baseline to 8 weeks
Functional competence 400 meter walk
Functional competence 400 meter walk is a test included in the European Consensus (EWGSOP2) to measure sarcopenia. Participant have to walk as fast as possible 400 meter. The total time is register.
Measured: Changes from baseline to 8 weeks
Change bone mineral density
Bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA). This is noninvasive technique. The result will be register in absolutes and percentages results.
Measured: Changes from baseline to 8 weeks
Change heart rate
Heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in number of pulse per minutes (heart rate).
Measured: Changes from baseline to 8 weeks
Gait speed change
Gait speed will be measure by 4. 6 and 10 meter test. This is easy physical test in with the participant have to walk 4. 6 and 10 metres as faster as possible. The result will be register in seconds. Less time indicates better functional ability.
Measured: Changes from baseline to 8 weeks
Time up and go test change
Time up and go test measure the functional capacity of getting up, walking and sitting down form a chair. Participant have to performance this test as faster as possible. This is a easy physical test. Total seconds are records. Less seconds indicates better functional ability.
Measured: Changes from baseline to 8 weeks
Short physical performance battery (SPPB)
Short physical performance battery (SPBB) include three test (balance, chair stand test and gait speed) and report a final score. Chair stand test and gait speed were describe in other outcome. Balance test is a easy physical test. The participant must maintain three balancing positions for 10 seconds to overcome it. Each test offers a different score. Higher score show better functional capacity.
Measured: Changes from baseline to 8 weeks
Change in lower limb strenght
Maximal isometric lower limb will be performance by maximal isometric strength of knee extension with load cell. Maximal isometric lower limb will be registered in newton. Higher value show high strength.
Measured: Changes from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jun 2022
- Primary completion1 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult DiseaseStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia González-Gálvez, Universidad Católica San Antonio de Murcia
- Investigators
- Pablo Jorge Marcos-Pardo, PhD, Principal investigator, Universidad de AlmeriaNoelia Gonzalez-Galvez, PhD, Principal investigator, UCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958499
- Sponsor's protocol ID
- UCMurcia-BiohealthyPark
- Status last verified
- May 2024
- First submitted
- 22 Jun 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcos-Pardo PJ, Abelleira-Lamela T, Vaquero-Cristobal R, Gonzalez-Galvez N. Changes in life satisfaction, depression, general health and sleep quality of Spanish older women during COVID-19 lockdown and their relationship with lifestyle: an observational follow-up study. BMJ Open. 2022 Aug 24;12(8):e061993. doi: 10.1136/bmjopen-2022-061993.
PubMed 36002204
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Psychological Effectiveness of Bio-Healthy Park on Adult
- ClinicalTrials.gov ID
- NCT04958499
- Acronym / sponsor ID
- UCMurcia-BiohealthyPark
- Conditions
- Adult Disease
- Keywords
- Adults, Older, Physical activity, Exercise, Bio-healthy park, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 Jul 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.
Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance. Therefore, general objective of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and Mediterranean diet adherence in adults and older adults. The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study. It will be measure body composition, bone mineral density, blood pressure, upper limb strength, lower limb strength, functional capacity, sarcopenia, sagittal disposition of the spine, Health-related quality of life, satisfaction with life and Mediterranean diet adherence. Experimental group will receive the exercise program on bio-healthy park machine with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The control group will not perform any intervention program following their usual activity.
Detailed description
The aging process is associated with physiological, psychological and functional deterioration. It has been demonstrated that the practice of physical activity can prevent, slow or reduce this deterioration. Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance.
Therefore, the objectives of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks, with a frequency of 2 sessions per week on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and mediterranean diet satisfaction in adults and older adults.
The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study.
The inclusion criteria are: (a) not having participated in a structured exercise program for at least 1 year, (b) being older than 50 years of age, and (c) being physically independent. The exclusion criteria are: (a) having musculoskeletal injuries or limitations that could affect the health and physical performance of the person; (b) being under medical prescription for taking medications that could influence physical performance; (c) not regularly attending the proposed sessions.
Body composition and bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA).
Blood pressure by means of an automatic device (Colin BP 880, Inc., Tampa, FL). Strength by manual dynamometry (TKK 5401; Co., Ltd., Tokyo, Japan) and maximal isometric strength of knee extension and biceps flexion.
Functional capacity will be assessed by means of the Chari stand test, gait speed, time up and go test and Short physical performance battery (SPPB), Sarcopenia will be assessed taking into account the reference values established for muscle quality (hand grip strength and chair stand test), muscle quantity (DEXA fat-free mass) and functional competence (gait speed, time up and go test, SPPB and 400 meter walk) established by the European Consensus (EWGSOP2).
The Spinal Mouse device (Switzerland) will be used to assess the sagittal disposition of the spine (thoracic curve, lumbar curve and pelvic tilt) in standing and relaxed sitting. This technique is non-invasive.
Health-related quality of life and satisfaction with life will be assessed by means of the SF36 and The Satisfaction with Life Scale (SWL) questionnaires.
Mediterranean diet adherence will be assess with a Mediterranean diet adherence questionaire.
Experimental group 1 will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The machines used will be rider, low gemini, high gemini, walk, bottoms, flywheels circles, flywheels rotation, twin swing, surf, swing press and rowing. Intensity will be controlled by subjective perception of effort and heart rate (Polar 420). There will be a warm-up 8-10 minutes, a main part 40-45 minutes and a return to calm 5-10 minutes. The intervention programs will be developed by a graduate in Physical Activity and Sport Sciences. The load will be progressed every 2 weeks. The control group will not perform any intervention program following their usual activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Healthy Park | Experimental | Behavioral: Bio-healthy ParkThis group is the experimental group. The intervention program consisted in the realization of the program on bio-healthy machinery. |
| Control | No intervention | –Adults and older assigned to the control group will not received any structured exercise programme. They will maintain their usual physical activities. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- not having participated in a structured exercise program for at least 1 year;
- being older than 50 years of age
- being physically independent.
Key exclusion criteria (3 listed)
- having musculoskeletal injuries or limitations that could affect the person's health and physical performance
- being under medical prescription for taking medications that could influence physical performance
- not regularly attending the proposed sessions.
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 |
|---|---|---|
| Bio-healthy ParkExperimental group will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. Experimental group 1 will perform the intervention program using machinery designed for self-loading use. The machines used will be rider, low gemini, high gemini, walk, bottoms, flywheels circles, flywheels rotation, twin swing, surf, swing press and rowing. Intensity will be controlled by subjective perception of effort and heart rate (Polar 420). There will be a warm-up 8-10 minutes, a main part 40-45 minutes and a return to calm 5-10 minutes. The intervention programs will be developed by a graduate in Physical Activity and Sport Sciences. The load will be progressed every 2 weeks. | Behavioural | Bio-Healthy Park |
Primary outcome
Muscle quality sarcopenia
Time frame: Changes from baseline to 8 weeks
Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.
15 secondary outcomes
Change Body composition
Time frame: Changes from baseline to 8 weeks
Change Blood pressure
Time frame: Changes from baseline to 8 weeks
Change Chair stand test
Time frame: Changes from baseline to 8 weeks
Change Upper strength
Time frame: Changes from baseline to 8 weeks
Change Sagittal spinal curvature
Time frame: Changes from baseline to 8 weeks
Health-related quality
Time frame: Changes from baseline to 8 weeks
Satisfaction with Life Scale (SWL)
Time frame: Changes from baseline to 8 weeks
Adherence to the Mediterranean diet
Time frame: Changes from baseline to 8 weeks
Functional competence 400 meter walk
Time frame: Changes from baseline to 8 weeks
Change bone mineral density
Time frame: Changes from baseline to 8 weeks
Change heart rate
Time frame: Changes from baseline to 8 weeks
Gait speed change
Time frame: Changes from baseline to 8 weeks
Time up and go test change
Time frame: Changes from baseline to 8 weeks
Short physical performance battery (SPPB)
Time frame: Changes from baseline to 8 weeks
Change in lower limb strenght
Time frame: Changes from baseline to 8 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 8 May 2024.
- Derived from this study: PubMed 36002204Marcos-Pardo PJ, Abelleira-Lamela T, Vaquero-Cristobal R, Gonzalez-Galvez N. Changes in life satisfaction, depression, general health and sleep quality of Spanish older women during COVID-19 lockdown and their relationship with lifestyle: an observational follow-up study. BMJ Open. 2022 Aug 24;12(8):e061993. doi: 10.1136/bmjopen-2022-061993.
- Individual participant dataSharing planned: No
Related trials for Adult Disease
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
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.
Pablo Jorge Marcos-Pardo, PhD principal investigator
Universidad de Almeria
Noelia Gonzalez-Galvez, PhD principal investigator
UCAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-healthy Park in people with Adult Disease, run by Universidad Católica San Antonio de Murcia 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 3 inclusion and 3 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 8 May 2024. 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?
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?
Muscle quality sarcopenia (time frame: Changes from baseline to 8 weeks). 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 NCT04958499, which also lists 1 linked publication.
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 8 May 2024.