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)
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: 1. Digital exercise program with personal coaching (Intervention Group 1) 2. Digital exercise program without personal coaching (Intervention Group 2) 3. 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. The primary outcomes are the mean daily step count (first) and mean daily walking distance (second), derived from a body-fixed sensor attached to the participant's lower back for a maximum measurement period of 7 consecutive days using the newest validated processing alogorithms. Secondary outcomes include additional DMOs (e.g., walking duration, number of walking bouts, walking speed, stride length, cadence), life-space mobility, physical capacity, hip pain and function, psychological and cognitive factors (e.g., concerns about falling, executive functioning), falls, intervention adherence and acceptability, health-related resource use, intervention delivery costs, and safety. The primary study hypothesis is that the combination of the digital exercise program and personal coaching will lead to higher PA six months after THA compared to usual care. Secondary hypotheses are that (1) the digital exercise program alone will increase PA compared to usual care, and (2) the combination of the digital exercise program and personal coaching will increase PA compared to the digital exercise program alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
213
KOKU is a digital adaptation of the evidence based Otago Exercise Program and Falls Management Exercise program, both designed to improve strength, balance, and reduce fall risk in older adults. KOKU includes 26 balance and strength exercises of varying difficulty. Each exercise is accompanied by written and audio instructions for safe performance and is demonstrated by a virtual trainer. Training sessions consist of three exercises suggested by the KOKU app, which participants are encouraged to perform for as many repetitions as possible until fatigue. Progression is guided by the participant's subjective assessment of effort and difficulty. Participants may choose to perform any exercise at any time, regardless of the app-suggested sequence. The KOKU app also provides reminders to exercise if no activity is detected for two days.
Personal coaching consists of three video calls conducted via the study tablet by staff trained in BCTs and motivational communication skills. Participants receive a low cost, wrist worn activity tracker during the initial home visit to support self-monitoring and provide feedback on PA behavior. The first virtual coaching session (week 2) focuses on goal setting and action planning, the second session (week 3) addresses identification and management of barriers, and the third session (week 12) serves as a booster to review and adjust activity goals for the post intervention period.
Department of Orthopaedics, Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGDaily step count
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.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily walking distance
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.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily walking duration
Mean daily walking duration \[h/day\] 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.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily walking bout count
Mean daily walking bout count \[#/day\] 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. Mean daily walking bout count is determined for walking bouts \>10 s, \>30 s, and \>60 s.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life walking bout duration
Mean and 90th percentile daily-life walking bout durations \[s\] 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.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life walking speed
Mean and 90th percentile daily-life walking speed \[m/s\] are 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. Mean and 90th percentile walking speeds are determined for shorter walking bouts (10-30 s) and for longer walking bouts (\>30 s).
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life stride length
Mean daily-life stride length \[cm\] 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. Mean stride length is determined for shorter (10-30 s) and longer (\>30 s) walking bouts.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life stride duration
Mean daily-life stride duration \[s\] 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. Mean stride duration is determined for all walking bouts and for longer walking bouts (\>30 s).
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life cadence
Mean and 90th percentile daily-life cadence \[steps/min\] 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. Mean cadence is determined for all walking bouts and for longer walking bouts (\>30 s), and the 90th percentile cadence for longer walking bouts (\>30 s).
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life walking variability
Bout-to-bout variability \[%\] in walking bout duration, walking speed and stride length for longer walking bouts (\>30 s), cadence and stride duration for all walking bouts, derived from a body-fixed sensor (AX6, Axivity Ltd.) worn on the participant's lower back over a maximum of 7 consecutive days, based on validated processing algorithms.
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (a)
6-Minute Walk Test (instrumented with the mTEST³ system \[mHealth Technologies srl, Bologna, Italy\] to capture spatio-temporal gait parameters)
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (b)
Timed Up and Go (instrumented with the mTEST³ system \[mHealth Technologies srl, Bologna, Italy\] to measure durations of sit-to-walk, walking, turning, and sitting segments)
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (c)
30-Second Chair Stand Test
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (d)
4-Meter Gait Speed Test
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Hip pain and function
Oxford Hip Score
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Life-space mobility
University of Alabama at Birmingham Life-Space Assessment
Time frame: 1 week preoperatively (T1), and 6 months postoperatively (T3)
Concerns about falling
Short Falls Efficacy Scale-International
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Health-related quality of life
European Quality of Life 5 Dimensions 5 Level index
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Self-perceived health status
EuroQol Visual Analogue Scale
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Change in self-perceived walking ability
7-point Global Rating of Change Scale (1= markedly worse, 7 = markedly better)
Time frame: 6 weeks postoperatively (T2) and 6 months postoperatively (T3)
Self-reported physical activity level
University of California Los Angeles Activity Score
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Conscientiousness
Conscientiousness dimension of Big Five Inventory-2
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Exercise motivation
Behavioural Regulation in Exercise Questionnaire
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Rate of falls
Daily fall calendars
Time frame: From 6 weeks postoperatively (T2) to 6 months postoperatively (T3)
Executive functioning
Trail Making Test A \& B
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Health-related resource use
Questionnaire for Health-Related Resource Use in an Elderly Population
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
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