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注册号: Registration number: |
ChiCTR2600126057 |
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最近更新日期: Date of Last Refreshed on: |
2026-06-03 10:12:55 |
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注册时间: Date of Registration: |
2026-06-03 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
Reformer Pilates Improves Posture and Functional Movement Regardless of AI-Assisted Personalisation: A Randomised Study |
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Public title: |
Reformer Pilates Improves Posture and Functional Movement Regardless of AI-Assisted Personalisation: A Randomised Study |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
Comparison of an 8-Week ChatGPT-Assisted, Weekly-Adaptive Reformer Pilates Programme with a Fixed Traditional Reformer Pilates Protocol on Postural Alignment and Functional Movement Quality in Healthy Recreational-Trained Adults: A Randomised Pre-Test/Post-Test Experimental Trial |
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Scientific title: |
Comparison of an 8-Week ChatGPT-Assisted, Weekly-Adaptive Reformer Pilates Programme with a Fixed Traditional Reformer Pilates Protocol on Postural Alignment and Functional Movement Quality in Healthy Recreational-Trained Adults: A Randomised Pre-Test/Post-Test Experimental Trial |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
Naci Kalkan |
研究负责人: |
Naci Kalkan |
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Applicant: |
Naci Kalkan |
Study leader: |
Naci Kalkan |
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申请注册联系人电话: Applicant telephone: |
+90 533 059 03 62 |
研究负责人电话:
Study leader's |
+90 533 059 03 62 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
naci.kalkan@cbu.edu.tr |
研究负责人电子邮件: Study leader's E-mail: |
naci.kalkan@cbu.edu.tr |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
https://orcid.org/0000-0003-4382-3210 |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
https://orcid.org/0000-0003-4382-3210 |
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申请注册联系人通讯地址: |
Manisa Celal Bayar University - Sport Science Faculty |
研究负责人通讯地址: |
Manisa Celal Bayar University - Sport Science Faculty |
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Applicant address: |
Manisa Celal Bayar University - Sport Science Faculty |
Study leader's address: |
Manisa Celal Bayar University - Sport Science Faculty |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
Manisa Celal Bayar University - Sport Science Faculty |
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Applicant's institution: |
Manisa Celal Bayar University - Sport Science Faculty |
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研究负责人所在单位: |
Manisa Celal Bayar University - Sport Science Faculty |
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Affiliation of the Leader: |
Manisa Celal Bayar University - Sport Science Faculty |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
20.478.486 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
Manisa Celal Bayar University, Faculty of Medicine, Health Sciences Ethics Committee |
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Name of the ethic committee: |
Manisa Celal Bayar University, Faculty of Medicine, Health Sciences Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-03-12 00:00:00 | ||
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伦理委员会联系人: |
Mehmet Murat Demet |
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Contact Name of the ethic committee: |
Mehmet Murat Demet |
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伦理委员会联系地址: |
Uncubozköy, 45030 Yunusemre/Manisa, Türkiye |
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Contact Address of the ethic committee: |
Uncubozköy, 45030 Yunusemre/Manisa, Türkiye |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+90 236 233 51 77 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
mehmet.murat.demet@cbu.edu.tr |
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研究实施负责(组长)单位: |
Manisa Celal Bayar University (Manisa Celal Bayar Üniversitesi) |
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Primary sponsor: |
Manisa Celal Bayar University (Manisa Celal Bayar Üniversitesi) |
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研究实施负责(组长)单位地址: |
Manisa Celal Bayar University, Şehit Prof. Dr. İlhan Varank Campus, 45140 Yunusemre, Manisa, Turkey |
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Primary sponsor's address: |
Manisa Celal Bayar University, Şehit Prof. Dr. İlhan Varank Campus, 45140 Yunusemre, Manisa, Turkey |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
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Source(s) of funding: |
No external funding. The study was conducted as part of a master's thesis project at Manisa Celal Bayar University. Institutional facilities (Pilates studio, equipment, ethics review) were provided by Manisa Celal Bayar University at no cost to the investigators. |
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研究疾病: |
Postural deviations and functional movement quality in healthy recreational-trained adults |
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Target disease: |
Postural deviations and functional movement quality in healthy recreational-trained adults |
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研究疾病代码: |
Z00.0 (Healthy adults — general adult medical examination) |
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Target disease code: |
Z00.0 (Healthy adults — general adult medical examination) |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
治疗新技术临床试验 | ||||||||||||||||||||||
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Study phase: |
New Treatment Measure Clinical Study |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
To compare the effects of an 8-week ChatGPT-assisted, weekly-adaptive Reformer Pilates programme with a fixed instructor-designed Reformer Pilates programme of equivalent training volume on postural alignment (assessed by APECS photogrammetry at five anatomical landmarks: ears, shoulders, ASIS, knees, feet) and functional movement quality (assessed by all seven Functional Movement Screen subtests) in healthy recreational-trained adults aged 20-45 years with a minimum of 6 months prior Pilates experience. The primary hypothesis was that the AI-assisted personalisation would yield superior outcomes compared with the traditional fixed protocol. |
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Objectives of Study: |
To compare the effects of an 8-week ChatGPT-assisted, weekly-adaptive Reformer Pilates programme with a fixed instructor-designed Reformer Pilates programme of equivalent training volume on postural alignment (assessed by APECS photogrammetry at five anatomical landmarks: ears, shoulders, ASIS, knees, feet) and functional movement quality (assessed by all seven Functional Movement Screen subtests) in healthy recreational-trained adults aged 20-45 years with a minimum of 6 months prior Pilates experience. The primary hypothesis was that the AI-assisted personalisation would yield superior outcomes compared with the traditional fixed protocol. |
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药物成份或治疗方案详述: |
Both groups completed an 8-week Reformer Pilates programme delivered twice weekly in 60-minute sessions (16 sessions total). Each session included a 10-minute warm-up (diaphragmatic breathing, gentle spinal articulation, shoulder mobilisation), 40 minutes of main exercise content, and a 10-minute cool-down (static stretching, guided relaxation breathing). The Traditional Group followed a fixed instructor-designed protocol structured in four two-week progressive loading blocks (Foundation, Progressive Load, Integration, Advanced Consolidation). The AI-Assisted Group received weekly programme updates generated by ChatGPT-4 (OpenAI) using a structured prompt incorporating each participant's weekly performance metrics: sit-and-reach (cm), single-leg stance duration (s), abdominal curl count (reps), and plank duration (s). All AI-generated programmes were reviewed by a Level 2 certified Reformer Pilates instructor before delivery. Equipment: Combo Cadillac Reformer units; resistance bands; Pilates balls (65 cm); magic circles. |
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Description for medicine or protocol of treatment in detail: |
Both groups completed an 8-week Reformer Pilates programme delivered twice weekly in 60-minute sessions (16 sessions total). Each session included a 10-minute warm-up (diaphragmatic breathing, gentle spinal articulation, shoulder mobilisation), 40 minutes of main exercise content, and a 10-minute cool-down (static stretching, guided relaxation breathing). The Traditional Group followed a fixed instructor-designed protocol structured in four two-week progressive loading blocks (Foundation, Progressive Load, Integration, Advanced Consolidation). The AI-Assisted Group received weekly programme updates generated by ChatGPT-4 (OpenAI) using a structured prompt incorporating each participant's weekly performance metrics: sit-and-reach (cm), single-leg stance duration (s), abdominal curl count (reps), and plank duration (s). All AI-generated programmes were reviewed by a Level 2 certified Reformer Pilates instructor before delivery. Equipment: Combo Cadillac Reformer units; resistance bands; Pilates balls (65 cm); magic circles. |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1. Concurrent enrolment in another structured resistance, movement, or rehabilitation programme; 2. History of spinal surgery or vertebral fracture; 3. Current pregnancy; 4. Inability to provide informed consent. |
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Exclusion criteria: |
1. Concurrent enrolment in another structured resistance, movement, or rehabilitation programme; 2. History of spinal surgery or vertebral fracture; 3. Current pregnancy; 4. Inability to provide informed consent. |
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研究实施时间: Study execute time: |
从 From 2025-03-20 00:00:00至 To 2025-07-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-03-25 00:00:00 至 To 2025-04-25 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
Simple randomisation. The allocation sequence was generated in advance by an independent researcher, not involved in recruitment, training delivery or outcome assessment, using the Microsoft Excel RAND function (Excel 2019, Microsoft Corporation, Redmond, WA, USA). The function produces uniform pseudo-random values, which were rank-ordered to yield an unbiased group sequence with 1:1 allocation ratio. |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Simple randomisation. The allocation sequence was generated in advance by an independent researcher, not involved in recruitment, training delivery or outcome assessment, using the Microsoft Excel RAND function (Excel 2019, Microsoft Corporation, Redmond, WA, USA). The function produces uniform pseudo-random values, which were rank-ordered to yield an unbiased group sequence with 1:1 allocation ratio. |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
Single-blind. Outcome assessor was blinded to group allocation throughout the study. The same trained researcher conducted all APECS photogrammetric evaluations and all FMS assessments without knowledge of participant group assignment. Participants and the instructor delivering the intervention were not blinded, as the nature of the intervention (personalised vs. fixed exercise programme) precluded participant and instructor blinding. To preserve assessor blinding, participants were explicitly instructed not to disclose their group assignment during assessment sessions, and assessment sessions for the two groups were scheduled on separate days. |
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Blinding: |
Single-blind. Outcome assessor was blinded to group allocation throughout the study. The same trained researcher conducted all APECS photogrammetric evaluations and all FMS assessments without knowledge of participant group assignment. Participants and the instructor delivering the intervention were not blinded, as the nature of the intervention (personalised vs. fixed exercise programme) precluded participant and instructor blinding. To preserve assessor blinding, participants were explicitly instructed not to disclose their group assignment during assessment sessions, and assessment sessions for the two groups were scheduled on separate days. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
De-identified individual participant data and analysis scripts are available from the corresponding author (naci.kalkan@cbu.edu.tr) on reasonable request, subject to a brief data-use statement. The pre-registered study protocol and statistical analysis plan are publicly available on the Open Science Framework: https://doi.org/10.17605/OSF.IO/VUGXM |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
De-identified individual participant data and analysis scripts are available from the corresponding author (naci.kalkan@cbu.edu.tr) on reasonable request, subject to a brief data-use statement. The pre-registered study protocol and statistical analysis plan are publicly available on the Open Science Framework: https://doi.org/10.17605/OSF.IO/VUGXM |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
Outcome data (APECS deviation scores, FMS subtest scores) were recorded on paper-based standardised case report forms (CRFs) immediately after each assessment session by the blinded outcome assessor. Data were subsequently entered into a password-protected Microsoft Excel 2019 spreadsheet by the principal investigator and double-checked against the original CRFs. Anthropometric data and weekly performance metrics for AI programme generation were recorded similarly. All paper records and electronic files are stored securely at Manisa Celal Bayar University in compliance with institutional data retention policies. No electronic data capture (EDC) system was used given the small sample size and single-site design. |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Outcome data (APECS deviation scores, FMS subtest scores) were recorded on paper-based standardised case report forms (CRFs) immediately after each assessment session by the blinded outcome assessor. Data were subsequently entered into a password-protected Microsoft Excel 2019 spreadsheet by the principal investigator and double-checked against the original CRFs. Anthropometric data and weekly performance metrics for AI programme generation were recorded similarly. All paper records and electronic files are stored securely at Manisa Celal Bayar University in compliance with institutional data retention policies. No electronic data capture (EDC) system was used given the small sample size and single-site design. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |