跳至主要内容
临床试验/NCT01484821
NCT01484821已完成不适用

Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer

University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
4
主要终点
Viscoelasticity of the contracted Tibialis anterior muscle

研究概览

简要总结

Sarcopenia is known to be associated with loss in muscle mass that results from a reduced number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia impairs muscle function resulting in a higher risk of physical disability and death. The commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle information. In contrast, the mechanical properties of muscle tissue can be explored using an acoustic radiation force impulse (ARFI). The question remains whether muscle sonoelastography using ARFI imaging could be helpful for sarcopenia screening.

For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both without any serious chronic disease, and patients ≥ 70 years presenting curative cares for cancer (Gr C).

The volunteers belonging to the groups A and B will be followed during one day. The patients included in the group C will be followed during 6 months. For this latter group; the first visit (t0) will take place before treatment and the second visit will take place 6 months later (t6months) Volunteers will have clinical examinations (weight, stature, BMI, performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk test, QLQ-C30 items relative to the fatigue symptom).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women 18 years old or more,
  • Able to understand the protocol and to give their written consent,
  • Health insurance.
  • Specific inclusion criteria:
  • Group A: volunteers 18 to 30 yrs; without any pathology,
  • Group B: volunteers ≥ 70 yrs; without any pathology,
  • Group C: Performance status (ECOG) < 4; patients included in CAPADOGE study presenting curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/or radiotherapy.

排除标准

  • Intense activity in 7 preceding days,
  • Functional dependency,
  • under a legal protection.
  • Specific non-inclusion criteria:
  • Groups A & B: serious chronic disease,
  • Group C: Palliative care.

研究组 & 干预措施

Arm C

Experimental

70 years patient or older with curative cares for cancer

干预措施: ARFI (Device)

Arm B

Active Comparator

Volunteers (70 years or older)

干预措施: ARFI (Device)

Arm A

Active Comparator

Volunteers (18 -30 years)

干预措施: ARFI (Device)

结局指标

主要结局

Viscoelasticity of the contracted Tibialis anterior muscle

时间窗: Day 1 (group A, B and C) and month 6 (group C only)

Describe and compare the distribution curves of viscoelasticity of the contracted Tibialis anterior muscle, measured by the ARFI shear wave velocity, between each group.

次要结局

  • Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles(Day 1 (group A, B and C) and month 6 (group C only))
  • Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles(Day 1 (group A, B and C) and month 6 (group C only))
  • Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles(Day 1 (group A, B and C) and month 6 (group C only))
  • Evaluate the influence of physical and/or nutritional status, age, and cancer pathology(Day 1 (group A, B and C) and month 6 (group C only))
  • Evaluate the intra-operator reproducibility(Day 1 (group A, B and C))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (4)

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