Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture. A Non-randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of the interventions; Adherence
研究概览
简要总结
The objective of this study is to examine if functional high-density, high-volume chair rise training is feasible for increasing lower extremity strength without causing excessive hip pain during execution in patients with hip fracture following a municipality -based outpatient rehabilitation program.
Feasibility criteria is defined as: 1) hip fracture-related pain might increase during the exercise programme, but not persistent after each session. 2) adherence to the program must be 75% or more. 3) Less than 20% drop-outs due to pain and/or discomfort during training.
详细描述
Background and rationale:
Hip fractures are associated with decrease in muscle strength, Rehabilitation after hip fractures typically include types of resistance training, functional training and cardiovascular training Factors affecting the functional prognosis after hip fracture surgery are multiple, and patients are at risk of decreased physical function new injurious falls and fractures and increased need of supportive care.
Earlier research has shown that daily on weekdays, progressive knee-extension strength training (three sets with a 10RM load) is a feasible and potentially effective treatment for increasing muscle strength in patients with hip fractures when commenced few days after surgery.
Extended physical therapy including strength training implemented about 6 weeks or later after hip fracture surgery seem to promote recovery of physical function.
The goal of rehabilitation is to reach the highest degree of autonomy as possible, which in sarcopenic older adults requires increasing the muscle strength in the lower extremities. Higher volume resistance training has been associated with increased muscle mass and strength in both young and older populations Resistance training for elderly patients is usually done to failure to ensure adequate volume for muscle hypertrophy and strength increases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study setting Training and data collection will be executed at a rehabilitation centre in Hørsholm municipality, capital region, Denmark.
- •Eligibility criteria Patients with hip fractures having
- •Referred to rehabilitation due to hip fracture
- •Age of 60 years or older
- •Cumulated Ambulation Score 5 or higher
排除标准
- •Moderate to severe dementia
- •Patients suffering from a severe medical condition not allowing them to follow a physical exercise program
- •Alcohol intake >21/14 units a week for men/women.
- •Patients not allowed full weight bearing on the fractured leg
- •Patients with 2 Hansson pins or similar procedure for cervical femoral fractures
研究组 & 干预措施
Phase 1
First subtrial (participants 1-10):
Sit-to-stand-to-sit training
干预措施: Basic intervention and nutritional intervention (Dietary Supplement)
Phase 1
First subtrial (participants 1-10):
Sit-to-stand-to-sit training
干预措施: Sit-to-stand (Procedure)
Phase 2
Second subtrial (participants 11-20):
Sit-to-stand and leg press training.
干预措施: Basic intervention and nutritional intervention (Dietary Supplement)
Phase 2
Second subtrial (participants 11-20):
Sit-to-stand and leg press training.
干预措施: Sit-to-stand (Procedure)
Phase 2
Second subtrial (participants 11-20):
Sit-to-stand and leg press training.
干预措施: Leg press (Procedure)
Phase 3
Third subtrial (participants 21-30):
Sit-to-stand and hip abduction training.
干预措施: Basic intervention and nutritional intervention (Dietary Supplement)
Phase 3
Third subtrial (participants 21-30):
Sit-to-stand and hip abduction training.
干预措施: Sit-to-stand (Procedure)
Phase 3
Third subtrial (participants 21-30):
Sit-to-stand and hip abduction training.
干预措施: Hip abduction (Procedure)
结局指标
主要结局
Feasibility of the interventions; Adherence
时间窗: Measured during the 8 week intervention
Feasibility is evaluated based on adherence to the program. Adherence to the program must be 75% or more, and drop outs due to pain or discomfort during training should be no more than 20%.
Tolerability of the interventions; Hip fracture related pain
时间窗: Measured during the 8 week intervention
Hip fracture-related pain during exercise, and dropouts. Hip fracture-related pain should not increase to more than a maximum of 3 VRS points (severe pain) during exercise and reduced thereafter, Patient rating pain on a verbal rating scale of 0-4 0: no pain, 1: slight pain, 2: Moderate pain, 3: severe pain and 4: Unbearable pain.
次要结局
- Change in 10m walk test, using regular walk speed and standing start.(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- New mobility score(Baseline(within the first week before starting the intervention) and immediately post intervention period,(including pre-fracture by recall))
- Change in Handgrip strength(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- Quality of life by EQ5D-5L(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- Sit-to-stand- test(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- SARC-F questionnaire(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- Prevalence and severity of sarcopenia(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- Falls Efficacy Scale-International(Baseline(within the first week before starting the intervention) and immediately post intervention period)
- Quality of life by EQ-VAS(Baseline(within the first week before starting the intervention) and immediately post intervention period)
研究者
Niklas Grundt Hansen
Research Therapist
Horsholm Municipality