Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty (PANORAMA). A Pragmatic, Randomized, Controlled, Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The number of participants that complete ≥ 8,000 steps per day
研究概览
简要总结
Total hip arthroplasty (THA) is considered an efficacious procedure for relieving pain and disability in patients with hip osteoarthritis. However, 6-12 months post-surgery physical activity level is unchanged compared to pre-surgery and still considerably lower than that of healthy peers. Increasing physical activity after THA may enhance the outcome of the THA because a graded relationship between physical activity level and functional performance has been documented. Six-8 months after THA physical function is only recovered to about 80% of that of healthy peers and older adults still seem to be at increased risk of frailty. Furthermore, these patients continue to impose higher healthcare costs than an age- and sex-matched reference population which potentially could be related to the functional status that is not completely regained. Finally, patients with hip osteoarthritis can have extensive comorbidity thus increasing physical activity after THA could be a simple and relatively inexpensive method for improving general health, which in turn may decrease healthcare costs.
The reasons for the lack of increase in physical activity despite increased capability after THA are unknown but it may be related to the sedentary behavior adopted by the patients prior to surgery and uncertainty. A systematic review has illuminated that patient-reported barriers to engaging in physical activity after THA are largely related to limited or inadequate information or education culminating in uncertainty about 'doing the right thing' for both the individual's recovery and the longevity of the joint replacement.
Few studies have investigated the effects of specific interventions to increase physical activity after THA. Promising results have been shown from physical activity sensors in combination with e.g. goal setting. None of these studies have addressed the patient-reported barriers to physical activity regarding uncertainty and limited education.
This trial aims to investigate the effect of adding a pedometer-driven, behavior change intervention to usual rehabilitation care 3 months after THA to increase physical activity compared to usual rehabilitation care alone (control). Outcomes are taken 3 (baseline), 6 (after the intervention period) and 12 months after THA (follow-up).
Hypothesis: the behavior change intervention will increase the proportion that completes ≥8,000 steps per day 6-month post-surgery to 50% versus 30% in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcome assessors will be blinded to group allocation and previous results and the participants are requested not to disclose their allocation when outcomes are assessed 6 and 12 months after surgery.
The biostatistician who perform the data analyses and validate the results will also be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Home dwelling, independent and self-reliant adults
- •Patients who has received primary total hip arthroplasty because of hip osteoarthritis
- •Informed consent to participate
排除标准
- •Planned joint arthroplasty in the lower extremities within the next 6 months
- •Patients who are unable to read, understand and speak Danish
- •Complications in relation to total hip arthroplasty e.g. dislocation, fracture or infection
- •Any other condition that in the opinion of the investigator makes a potential participant unfit for participation
研究组 & 干预措施
Behavior change intervention
A 3-month behavior change intervention i.e. one initial, face-to-face, physical activity counselling and two telephone-assisted counselling.
干预措施: Behavior change intervention (Behavioral)
Control
No attention
结局指标
主要结局
The number of participants that complete ≥ 8,000 steps per day
时间窗: 6 months after THA
The mean number of steps completed per day assessed by an accelerometer during a 7-day period.
次要结局
- The number of participants that complete ≥ 10,000 steps per day(6 months after THA)
- Change from baseline in hip pain(6 months after THA)
- Change from baseline in self-reported physical function(6 months after THA)
- The number of participants that complete ≥ 5,000 steps per day(6 and 12 months after THA)
- Health-related quality of life(6 and 12 months after THA)
- Change from baseline in the 6-minute walk test(6 months after THA)
- Change from baseline in the 30-s chair-stand test(6 months after THA)
- Change from baseline in the stair-climb test(6 months after THA)
- Change from baseline in the patients' assessment of global perceived effect(6 months after THA)
- The mean number of steps per day(6 months after THA)
研究者
Theresa Bieler
Research Therapist
Bispebjerg Hospital