Frail ElderlyN-CARE FrailtyNCT07418762
Community-Based Program Integrating Nurse-Led Mind-Body Exercise and Nutrition for Frailty
A study testing Nurse-Led Mind-Body Exercise (MBE) in people with Frail Elderly, run by Universitas Airlangga at 1 site in Indonesia.
Trial summary
This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Nurse-Led Mind-Body Exercise (MBE)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Mar 2026to 25 May 2026
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Eligibility criteria included age ≥65 years, a Frail Scale score of 1-3 (pre-frail) or 4-5 (frail), ability to stand and walk independently without permanent assistive devices, willingness to participate for eight weeks (three sessions per week), and provision of written informed consent.
Who cannot join
- Exclusion criteria included severe cardiac or respiratory conditions (contraindications to exercise), moderate to severe cognitive impairment (MoCA-Ina), recent stroke or severe musculoskeletal disorders, and known allergies or intolerance to protein supplements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D contact
Indonesia1 site
Universitas Airlangga
Surabaya, East Java, 60115
Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D, +6281330718027, ristafauzinigtyas@fkp.unair.ac.id
About this study
Official title: Community-Based Rehabilitation Integrating Nurse-Led Mind-Body Exercise and Nutritional Supplementation for Frailty: A Three-Arm Randomized Controlled Trial
This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. The intervention was conducted for 8 weeks in community-dwelling older adults aged ≥ 65 years who live within the working area of a Community Health Center in Surabaya City. The sample size is 48 elderly. Participants will be divided into 3 groups: the control group, the Nurse-Led Mind-Body Exercise group, and the MBE + Nutritional Supplementation (MBE + Nutrition) group. The procedure is carried out after respondents provide voluntary consent. Confidentiality and anonymity of data will be strictly maintained throughout the research process. Data analysis between groups and within groups will be conducted using repeated-measures ANOVA and Intention-to-treat (ITT) analysis.
Read the detailed description
The sample was selected based on inclusion and exclusion criteria. Inclusion criteria were age ≥ 65 years, FRAIL scale score of 0 (robust), 1-3 (pre-frail), and 4-5 (frail), able to stand and walk independently without permanent aids, willing to participate in the 8-week program (three sessions per week), and provide written consent. Exclusion criteria included severe heart or respiratory conditions that would contraindicate exercise, moderate to severe cognitive impairment (MoCA-InaMSE <18), recent stroke or severe musculoskeletal disorder, and known allergies or intolerances to protein supplements. 48 respondents were randomly assigned (stratified by gender and level of frailty) into one of three groups. Respondents who meet the criteria will be given a complete explanation of the research objectives, procedures, potential benefits, minimal risks, and the right to withdraw at any time without consequence. After understanding all this information, respondents will be asked to provide voluntary consent by signing an informed consent form. Once consent is granted, researchers will conduct direct data collection. In this study, subjects will undergo a series of research processes over several weeks. In week 1, direct data collection was conducted through physical examinations and measurements prior to the intervention. This process included measuring physical function using the Short Physical Performance Battery (SPPB) and the Time Up and Go Test (TUGT), measuring respiratory function using a peak flow meter, and examining body composition using Bioelectrical Impedance Analysis (BIA). In addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α.
Respondents in the control group in weeks 2, 3, and 4 will receive education about physical changes in the elderly, healthy lifestyle habits for healthy aging, and participate in integrated health service post (Posyandu) activities. In the following weeks, namely weeks 5, 6, 7, and 8, education will be provided about physical problems that occur in the elderly, activities carried out to prevent frailty, nutrition that helps prevent frailty, and participation in Posyandu activities. The implementation of education and Posyandu will be adjusted to the Posyandu schedule in the region. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on slow resistance, breath control, and relaxation. Exercises are carried out three times per week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): slow resistance training using resistance band tubing and balance and coordination exercises from Otago exercise, Cooling down (10 minutes): static stretching and breathing meditation with chair yoga. In the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro milk of 1.2 grams/kgBW/day during the 8-week intervention period, consumed daily after breakfast or after the exercise session. In addition, respondents will also receive an educational session on how to consume Ensure Gold Strength Pro milk. A sample of 16 participants per group was used as a reference because it is appropriate for detecting early trends in effectiveness in a community-based pilot study. Data analysis will include descriptive statistics related to the baseline characteristics of participants. Between-group and within-group comparisons will be conducted using mixed-effect models or repeated-measures ANOVA to assess changes over time and differences between intervention groups. Intention-to-treat (ITT) analysis will be applied to handle missing data, ensuring the reliability of the results. To control for potential type I error due to multiple comparisons, a Bonferroni correction will be applied. Statistical significance will be determined at a threshold of p < 0.05. This study will be reviewed and approved by the Ethics Committee of the Faculty of Nursing, Airlangga University. All participants will receive a detailed explanation of the study procedures and provide written informed consent before participating. Data confidentiality and anonymity will be strictly maintained throughout the study. This study carries minimal risk to participants, as all activities are performed at a low intensity, and continuous monitoring will be conducted during each session to ensure participant safety.
- Conditions
- Frail Elderly
- Being tested
- Nurse-Led Mind-Body Exercise (MBE)
- Keywords
- Frailty, Elderly, Nurse Led Mind-Body
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Mind-Body Exercise (MBE)Behavioural
The study will be conducted for 8 weeks. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on gentle resistance, breath control, and relaxation. The exercises will be conducted three times a week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): gentle resistance training using resistance band tubing and balance and coordination exercises from Otago exercise Cool-down (10 minutes): static stretching and breathing meditation with chair yoga. Meanwhile, in the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group received general health education on physical changes in older adults, healthy lifestyles for older adults, common physical problems in aging, frailty prevention activities, and appropriate nutrition to prevent frailty for eight weeks. |
| Nurse Led Mind-Body Exercise | Experimental | The mind-body exercise intervention group received a structured program led by trained nurses. The exercise sessions consisted of warm-up activities, strength training (resistance band/tubing), balance training (Otago Exercise), and cool-down activities (chair yoga). Sessions were conducted three times per week, 45 minutes per session, over an eight-week period. Receives: Behavioral: Nurse-Led Mind-Body Exercise (MBE) |
| Nurse Led Mind-Body Exercise and Nutritional Supplementation | Experimental | The mind-body exercise plus nutritional supplementation group received the same structured exercise intervention combined with daily protein supplementation in the form of Ensure Gold Strength Pro milk at a dose of 1.25 g/kg body weight per day for eight weeks, administered orally. Receives: Behavioral: Nurse-Led Mind-Body Exercise (MBE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frailty status of the elderly
Frailty status of the elderly will be measured using the Indonesian version of the FRAIL scale (Ina-FRAIL). Changes in frailty status will be evaluated by comparing Ina-FRAIL scores at baseline and after the intervention period
Measured: Baseline (Week 0) and post-intervention at Week 8
Secondary outcomes (5)
Changes in Lower Extremity Physical Performance of the Elderly
Lower extremity physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and standing from a chair. Changes in the total SPPB score will indicate improvement or decline in physical function related to mobility and frailty status.
Measured: Baseline (Week 0) and post-intervention at Week 8
Changes in Functional Mobility and Fall Risk of the Elderly
Functional mobility and fall risk will be measured using the Timed Up and Go Test (TUGT). The test will be used to assess changes in dynamic balance, mobility, and fall risk.
Measured: Baseline (Week 0) and post-intervention at Week 8
Changes in Pulmonary Function of the Elderly
Pulmonary function will be evaluated using a peak flow meter to measure Peak Expiratory Flow (PEF). Changes in PEF values will indicate alterations in respiratory capacity associated with physical conditioning.
Measured: Baseline (Week 0) and post-intervention at Week 8
Changes in Body Composition of the Elderly
Body composition, including muscle mass, fat mass, and body mass index (BMI), will be assessed using Bioelectrical Impedance Analysis (BIA). Changes in these parameters will be used to evaluate the effects of the intervention on nutritional and physical status.
Measured: Baseline (Week 0) and post-intervention at Week 8
Changes in Inflammatory Biomarkers Related to Frailty of the Elderly
Levels of inflammatory biomarkers, including Interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-α), will be measured using ELISA assays. Changes in biomarker concentrations will reflect inflammatory and metabolic responses related to frailty.
Measured: Baseline (Week 0) and post-intervention at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start30 Mar 2026 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sultan Zainal Abidin, Caritas Institute of Higher Education
- Responsible party
- Principal investigator, Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418762
- Sponsor's protocol ID
- Number: 4027-KEPK
- Other IDs
- 5461/B/UN3.LPPM/PT.01.03/2025
- Acronym
- N-CARE Frailty
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Rehabilitation Integrating Nurse-Led Mind-Body Exercise and Nutritional Supplementation for Frailty: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07418762
- Acronym / sponsor ID
- N-CARE Frailty / Number: 4027-KEPK
- Conditions
- Frail Elderly
- Keywords
- Frailty, Elderly, Nurse Led Mind-Body
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Collaborators
- Universiti Sultan Zainal Abidin, Caritas Institute of Higher Education
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. The intervention was conducted for 8 weeks in community-dwelling older adults aged ≥ 65 years who live within the working area of a Community Health Center in Surabaya City. The sample size is 48 elderly. Participants will be divided into 3 groups: the control group, the Nurse-Led Mind-Body Exercise group, and the MBE + Nutritional Supplementation (MBE + Nutrition) group. The procedure is carried out after respondents provide voluntary consent. Confidentiality and anonymity of data will be strictly maintained throughout the research process. Data analysis between groups and within groups will be conducted using repeated-measures ANOVA and Intention-to-treat (ITT) analysis.
Detailed description
The sample was selected based on inclusion and exclusion criteria. Inclusion criteria were age ≥ 65 years, FRAIL scale score of 0 (robust), 1-3 (pre-frail), and 4-5 (frail), able to stand and walk independently without permanent aids, willing to participate in the 8-week program (three sessions per week), and provide written consent. Exclusion criteria included severe heart or respiratory conditions that would contraindicate exercise, moderate to severe cognitive impairment (MoCA-InaMSE <18), recent stroke or severe musculoskeletal disorder, and known allergies or intolerances to protein supplements. 48 respondents were randomly assigned (stratified by gender and level of frailty) into one of three groups. Respondents who meet the criteria will be given a complete explanation of the research objectives, procedures, potential benefits, minimal risks, and the right to withdraw at any time without consequence. After understanding all this information, respondents will be asked to provide voluntary consent by signing an informed consent form. Once consent is granted, researchers will conduct direct data collection. In this study, subjects will undergo a series of research processes over several weeks. In week 1, direct data collection was conducted through physical examinations and measurements prior to the intervention. This process included measuring physical function using the Short Physical Performance Battery (SPPB) and the Time Up and Go Test (TUGT), measuring respiratory function using a peak flow meter, and examining body composition using Bioelectrical Impedance Analysis (BIA). In addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α.
Respondents in the control group in weeks 2, 3, and 4 will receive education about physical changes in the elderly, healthy lifestyle habits for healthy aging, and participate in integrated health service post (Posyandu) activities. In the following weeks, namely weeks 5, 6, 7, and 8, education will be provided about physical problems that occur in the elderly, activities carried out to prevent frailty, nutrition that helps prevent frailty, and participation in Posyandu activities. The implementation of education and Posyandu will be adjusted to the Posyandu schedule in the region. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on slow resistance, breath control, and relaxation. Exercises are carried out three times per week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): slow resistance training using resistance band tubing and balance and coordination exercises from Otago exercise, Cooling down (10 minutes): static stretching and breathing meditation with chair yoga. In the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro milk of 1.2 grams/kgBW/day during the 8-week intervention period, consumed daily after breakfast or after the exercise session. In addition, respondents will also receive an educational session on how to consume Ensure Gold Strength Pro milk. A sample of 16 participants per group was used as a reference because it is appropriate for detecting early trends in effectiveness in a community-based pilot study. Data analysis will include descriptive statistics related to the baseline characteristics of participants. Between-group and within-group comparisons will be conducted using mixed-effect models or repeated-measures ANOVA to assess changes over time and differences between intervention groups. Intention-to-treat (ITT) analysis will be applied to handle missing data, ensuring the reliability of the results. To control for potential type I error due to multiple comparisons, a Bonferroni correction will be applied. Statistical significance will be determined at a threshold of p < 0.05. This study will be reviewed and approved by the Ethics Committee of the Faculty of Nursing, Airlangga University. All participants will receive a detailed explanation of the study procedures and provide written informed consent before participating. Data confidentiality and anonymity will be strictly maintained throughout the study. This study carries minimal risk to participants, as all activities are performed at a low intensity, and continuous monitoring will be conducted during each session to ensure participant safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group received general health education on physical changes in older adults, healthy lifestyles for older adults, common physical problems in aging, frailty prevention activities, and appropriate nutrition to prevent frailty for eight weeks. |
| Nurse Led Mind-Body Exercise | Experimental | Behavioral: Nurse-Led Mind-Body Exercise (MBE)The mind-body exercise intervention group received a structured program led by trained nurses. The exercise sessions consisted of warm-up activities, strength training (resistance band/tubing), balance training (Otago Exercise), and cool-down activities (chair yoga). Sessions were conducted three times per week, 45 minutes per session, over an eight-week period. |
| Nurse Led Mind-Body Exercise and Nutritional Supplementation | Experimental | Behavioral: Nurse-Led Mind-Body Exercise (MBE)The mind-body exercise plus nutritional supplementation group received the same structured exercise intervention combined with daily protein supplementation in the form of Ensure Gold Strength Pro milk at a dose of 1.25 g/kg body weight per day for eight weeks, administered orally. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Eligibility criteria included age ≥65 years, a Frail Scale score of 1-3 (pre-frail) or 4-5 (frail), ability to stand and walk independently without permanent assistive devices, willingness to participate for eight weeks (three sessions per week), and provision of written informed consent.
Key exclusion criteria (1 listed)
- Exclusion criteria included severe cardiac or respiratory conditions (contraindications to exercise), moderate to severe cognitive impairment (MoCA-Ina), recent stroke or severe musculoskeletal disorders, and known allergies or intolerance to protein supplements.
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 |
|---|---|---|
| Nurse-Led Mind-Body Exercise (MBE)The study will be conducted for 8 weeks. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on gentle resistance, breath control, and relaxation. The exercises will be conducted three times a week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): gentle resistance training using resistance band tubing and balance and coordination exercises from Otago exercise Cool-down (10 minutes): static stretching and breathing meditation with chair yoga. Meanwhile, in the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro | Behavioural | Nurse Led Mind-Body Exercise, Nurse Led Mind-Body Exercise and Nutritional Supplementation |
Primary outcome
Changes in frailty status of the elderly
Time frame: Baseline (Week 0) and post-intervention at Week 8
Frailty status of the elderly will be measured using the Indonesian version of the FRAIL scale (Ina-FRAIL). Changes in frailty status will be evaluated by comparing Ina-FRAIL scores at baseline and after the intervention period
5 secondary outcomes
Changes in Lower Extremity Physical Performance of the Elderly
Time frame: Baseline (Week 0) and post-intervention at Week 8
Changes in Functional Mobility and Fall Risk of the Elderly
Time frame: Baseline (Week 0) and post-intervention at Week 8
Changes in Pulmonary Function of the Elderly
Time frame: Baseline (Week 0) and post-intervention at Week 8
Changes in Body Composition of the Elderly
Time frame: Baseline (Week 0) and post-intervention at Week 8
Changes in Inflammatory Biomarkers Related to Frailty of the Elderly
Time frame: Baseline (Week 0) and post-intervention at Week 8
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 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Mind-Body Exercise (MBE) in people with Frail Elderly, run by Universitas Airlangga at 1 site in Indonesia.
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 1 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: opening soon, as of the sponsor's last update on 18 Feb 2026. 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 Indonesia. 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?
Contact Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D (+6281330718027, ristafauzinigtyas@fkp.unair.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frailty status of the elderly (time frame: Baseline (Week 0) and post-intervention at Week 8). 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 18 Feb 2026.