Characterising SARcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over at Risk of Mobility Disability. An OBServational Clinical Trial (SARA-OBS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biophytis
- 入组人数
- 218
- 试验地点
- 7
- 主要终点
- 6-minute or 400 meters walk.
研究概览
简要总结
The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries, (Belgium, France and Italy), and in the US.
300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.
Participants aged ≥ 65 years complaining of poor physical function will be selected to perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI < 0.789 in men and 0.512 in women will be included. The investigational phase will comprise two main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test and the 400-metre walking test will be administered at the main visits. Patient Reported Outcomes (PROs) will be completed by the patients at the same visits.
详细描述
The SARA-OBS is a phase 2 clinical trial, with no investigational product and no therapeutic intervention. It will be conducted in three European countries, Belgium, France and Italy, and in the US.
300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.
The general objective is to characterise sarcopenia including "sarcopenic obesity" in a population of older persons living in the community and at risk of mobility disability; evaluate their physical performance and body composition in view of the design of a phase 2 clinical study on the efficacy and safety of BIO101 on the prevention of mobility disability in the at-risk community dwelling older adults (≥65 years) reporting loss of physical function.
The primary objective characterise sarcopenia including sarcopenic obesity, in older persons at risk of mobility disability. Sarcopenia will be defined according to the criteria of the Foundation of NIH; the risk of mobility disability will be operationalised by the Short Physical Performance Battery (SPPB). For this purpose, the 6-minute walking distance and the 400-meter walking test will be evaluated at 6-month intervals, in the absence of any therapeutic intervention. The incident rate of change will be estimated on the sample and pre-specified subgroups (e.g. gender, SPPB baseline score, etc.).
Two important Secondary Objectives are also included :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥ 65 years and living in the community, reporting loss of physical function
- •Short Physical Performance Battery (SPPB) score ≤ 8
- •ALM/BMI < 0.789 in men and 0.512 in women, by DXA scan
排除标准
- •Unable or unwilling to provide informed consent
- •Unable to understand and perform the functional tests, as judged by the Investigator
- •Current treatment with anabolic drugs, i.e. testosterone
- •Clinical conditions:
- •Current diagnosis major psychiatric disorders.
- •Alcohol abuse or dependence
- •Severe arthritis
- •Cancer requiring active treatment
- •Lung disease requiring regular use of supplemental oxygen
- •Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents
- •Severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
- •Parkinson's disease or other progressive neurological disorder
- •Renal disease requiring dialysis
- •Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline the 6MWT, or the 400-meter walk test
- •Current physical/rehabilitation therapy
- •Current enrolment in another clinical trial
- •Concomitant condition implying life expectancy ≤ 6 months
- •Any other condition precluding the regular participation to the clinical trial, as judged by the Investigator.
结局指标
主要结局
6-minute or 400 meters walk.
时间窗: Change from Baseline 6 minute or 400 meters to measurement at 6 months.
The 6 minutes walking distance is a functional exercise capacity test that involves measuring the distance covered by a participant within a specified time of 6 minutes. The 400 meter walking test is a measure of how long it will take for a volunteer to complete the specified 400 meters distance.
次要结局
- SPPB(Change from Baseline SPPB to measurement at 6 months.)
- DEXA(Change from Baseline DEXA to measurement at 6 months.)
- Stair Climb Power Test(Change from Baseline Stair Climb Power Test to measurement at 6 months.)
- Actimetry(Change from actimetry at Month1 to measurement at 6 months.)
- Grip strength(Change from Baseline Grip Strength to measurement at 6 months.)
- Knee extension(Change from Baseline knee extension to measurement at 6 months.)
- Patient Reported Outcome : SF-36(Change from Baseline Patient Reported Outcome to measurement at 6 months.)
- Patient Reported Outcomes : SarQoL(Change from Baseline Patient Reported Outcome to measurement at 6 months.)
- Patient Reported Outcomes TSC-OD for patients with BMI>30(Change from Baseline Patient Reported Outcome to measurement at 6 months.)
- Patient Reported Outcomes (PAT-D)(Change from Baseline Patient Reported Outcome to measurement at 6 months.)
- Biomarkers(Change from Baseline Biomarkers to measurement at 6 months)