iPATH - Digital Home-Based Training for Physical Activity Promotion in Older Adults After Total Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Daily step count
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of a 12-week digital home-based intervention program, consisting of a tablet-based exercise program with or without personal coaching, to promote physical activity (PA) in older adults after total hip arthroplasty (THA). The main question it aims to answer is:
• Does the combination of the digital exercise program and personal coaching lead to higher PA six months after THA compared to usual care among older adults?
Secondary questions are:
- Does the digital exercise program alone lead to higher PA compared to usual care?
- Does the digital exercise program combined with personal coaching lead to higher PA compared to the exercise program alone?
Participants' PA will be objectively measured with a body-fixed sensor at 1 week before THA (T1), 6 weeks after THA (T2), and 6 months (i.e. after THA (T3). After the postoperative assessment at T2, participants will be randomly assigned to one of three groups:
- 12-week tablet-based exercise program at home with virtual personal coaching for physical activity promotion
- 12-week tablet-based exercise program at home
- Usual care (control group, no additional intervention)
详细描述
Hip osteoarthritis is common in older adults and is associated with limitations in activities of daily living, mobility, and quality of life. THA effectively reduces pain and improves physical functioning. However, patients often show no or only minimal increase in their typically low preoperative PA after THA. This lack of PA improvements may result from short rehabilitation periods, persistent sedentary habits, and methodological limitations of PA monitoring methods that focus mainly on frequency or temporal parameters (e.g. step count, walking or active durations).
Digital home-based training programs offer an opportunity for patients to continue structured exercises independently and at flexible times, extending postoperative care beyond standard rehabilitation. In addition, personal coaching that applies behavioral change techniques (BCTs) such as goal setting, action planning, self-monitoring with feedback, and barrier identification and management, may help break sedentary habits and promote PA. Recent advances in wearable sensor technology and processing algorithms now also enable a more detailed monitoring of real-world digital mobility outcomes (DMOs), allowing also capturing spatial-related parameters (e.g., walking distance, stride length, gait speed).
The iPATH study is a three-armed, assessor-blinded, randomized, parallel-group clinical trial evaluating the efficacy of two 12-week digital home-based intervention programs to promote PA in 213 older adults after THA:
- Digital exercise program with personal coaching (Intervention Group 1)
- Digital exercise program without personal coaching (Intervention Group 2)
- Usual care (Control Group) - no additional intervention
Outcome assessments are conducted at 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3; operationally defined as 26 weeks after THA). Randomization occurs after the T2 assessment, which typically coincides with the end of standard inpatient or outpatient rehabilitation. The digital home-based exercise program in the two intervention arms is based on the Keep-On-Keep-Up (KOKU) app, which includes progressive strength and balance exercises to be performed three times per week. Personal coaching includes three virtual sessions designed to promote PA behavior change using BCTs (goal setting, action planning, self-monitoring and feedback [activity tracker], barrier identification and management). Participants in the control group also receive a tablet but have no access to the KOKU app and do not receive any personal coaching sessions.
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
Biostatistician responsible for data analysis remains blinded until the database is locked.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Coxarthrosis with indication for total hip arthroplasty
- •Residence within a radius of ≤50 km from Heidelberg
- •Ability to walk ≥10 m (with/without walking aid)
- •Access to the internet (Wi-Fi) at home
- •Written informed consent
排除标准
- •Insufficient German language skills
- •Insufficient hearing to communicate via (video) telephone
- •Insufficient vision to recognize study materials
- •Contralateral coxarthrosis with indication for total hip arthroplasty
- •Severe medical condition illnesses that compromise physical fitness (heart failure classified as New York Heart Association [NYHA] class ≥3, heart valve defects associated with syncope, cardiac arrhythmia with dizziness, chronic obstructive pulmonary disease [COPD] with oxygen therapy, cancer with chemotherapy and/or radiation, Parkinson's disease with rollator use [Hoehn & Yahr stage ≥4])
- •Living in a nursing home
- •Planned major medical procedure within the next 6 months with inpatient hospital stay (e.g., further surgery)
- •Simultaneous participation in another competing study
- •Cognitive impairment (6-item Cognitive Impairment Test [6CIT] score >7 points)
结局指标
主要结局
Daily step count
时间窗: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Mean daily step count \[#/day\] is derived from a body-fixed sensor (AX6, Axivity Ltd.) attached to the participant's lower back for a maximum measurement period of 7 consecutive days, using validated processing algorithms.
Daily walking distance
时间窗: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Mean daily cumulative walking distance \[m/day\] is derived from a body-fixed sensor (AX6, Axivity Ltd.) worn on the participant's lower back over a maximum measurement period of 7 consecutive days, based on validated processing algorithms.
Daily step count
时间窗: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Mean daily step count \[#/day\] is derived from a body-fixed sensor (AX6, Axivity Ltd.) attached to the participant's lower back for a maximum measurement period of 7 consecutive days, using validated processing algorithms.
Daily walking distance
时间窗: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Mean daily cumulative walking distance \[m/day\] is derived from a body-fixed sensor (AX6, Axivity Ltd.) worn on the participant's lower back over a maximum measurement period of 7 consecutive days, based on validated processing algorithms.
次要结局
- Daily-life walking speed(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily walking duration(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily walking bout count(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life walking bout duration(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life stride length(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life stride duration(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life cadence(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life walking variability(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Physical capacity (a)(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Physical capacity (b)(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily walking duration(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily walking bout count(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life walking bout duration(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life walking speed(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life stride length(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life stride duration(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life cadence(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Daily-life walking variability(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Physical capacity (a)(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Physical capacity (b)(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Physical capacity (c)(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Physical capacity (d)(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Hip pain and function(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Life-space mobility(1 week preoperatively (T1), and 6 months postoperatively (T3))
- Concerns about falling(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Health-related quality of life(1 week preoperatively (T1) and 6 months postoperatively (T3))
- Self-perceived health status(1 week preoperatively (T1) and 6 months postoperatively (T3))
- Change in self-perceived walking ability(6 weeks postoperatively (T2) and 6 months postoperatively (T3))
- Self-reported physical activity level(1 week preoperatively (T1) and 6 months postoperatively (T3))
- Conscientiousness(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Exercise motivation(1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3))
- Rate of falls(From 6 weeks postoperatively (T2) to 6 months postoperatively (T3))
- Executive functioning(1 week preoperatively (T1) and 6 months postoperatively (T3))
- Health-related resource use(1 week preoperatively (T1) and 6 months postoperatively (T3))
研究者
Tobias Reiner
Priv.-Doz. Dr. med.
University Hospital Heidelberg