Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Practicality of the study protocol - Human ressources needed
研究概览
简要总结
This project aims to investigate the feasibility of a low load (LL) isokinetic knee flexor and extensor strength training (ST) protocol under blood flow restriction (BFR) conditions in early postoperative total knee arthroplasty patients.
The intervention consists in testing an experimental strengthening protocol in the Leukerbad Clinic. 12 participants will be recruited and the intervention will last approximatively 3 weeks and will consist in 3 weekly ST.
The collected data will then be analysed and interpreted to define if such an intervention is feasible or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary TKA surgery less than 12 days before inclusion
- •Ability to participate fully in physiotherapy
- •Ability to consent for study participation
- •Age between 50 and 80 years old
排除标准
- •Postoperative complication
- •History of deep venous thrombosis
- •History of vascular pathology
- •History of metabolic condition
- •Previous contralateral TKA
- •Previous ipsilateral or contralateral total hip arthroplasty
- •Any other lower extremity musculoskeletal chronic condition
- •Any lower extremity injury within the last 6 months
- •Pregnancy
- •Sickle cell trait
- •History of neurocognitive disorders
- •Inability to follow the intervention protocol
结局指标
主要结局
Practicality of the study protocol - Human ressources needed
时间窗: During the procedure (approximatively 3 weeks long)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: human resources needed.
Practicality of the study protocol - Time to teach the protocol to the personnel
时间窗: Before the beginning of the procedure
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed to teach the protocol to the personnel in minutes
Practicality of the study protocol - Time needed for the pre-tests
时间窗: Day 1 post-inclusion
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the pre-tests in minutes
Practicality of the study protocol - Time needed for the post-tests
时间窗: Last day of the intervention
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the post-tests in minutes
Practicality of the study protocol - Recruitment rates
时间窗: During the recruitment period (6months)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the recruitment rates by evaluating the number of volunteers recruited within 6 months.
Practicality of the study protocol - Time needed for the intervention
时间窗: During the procedure (approximatively 3 weeks long)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the intervention in minutes
Acceptability of the intervention
时间窗: Up to three weeks (duration of the intervention)
The domain acceptability focuses on how the individuals involved in the study react to the intervention (Bowen et al., 2009). We will assess both the satisfaction with the intervention protocols and the perceived positive and negative effects during and after the intervention protocols. Both outcomes will be evaluated with the visual analogue scale (VAS).
Practicality of the study protocol - Costs
时间窗: From date of acceptation of the project (April 2022) to the anticipated end of the project (December 2023), assessed up to 90 weeks
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Practicality of the study protocol - Retention rates
时间窗: During the recruitment period (6months)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the retention rates by counting the number of dropouts and analysing the compliance/adherence rates. And finally, we will evaluate the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
次要结局
- Preliminary data on benefits - Strength(During the procedure (approximatively 3 weeks long))
- Preliminary data on benefits - Pain(During the procedure (approximatively 3 weeks long))
- Preliminary data on benefits - Functionality(Up to three weeks (duration of the intervention))