Total Hip Arthroplasty (THA)iPATHNCT07135843
Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty
A study testing Digital exercise program and Personal coaching for physical activity promotion in people with Total Hip Arthroplasty (THA) and Older Adults (65 Years and Older), run by Heidelberg University at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA), Older Adults (65 Years and Older)
- What is being tested?
- Digital exercise program and Personal coaching for physical activity promotion
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Orthopaedics, Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69118
Tobias Reiner, Priv.-Doz. Dr. med., +49 (0)6221 25000, tobias.reiner@med.uni-heidelberg.de
About this study
Official title: iPATH - Digital Home-Based Training for Physical Activity Promotion in Older Adults After Total Hip Arthroplasty: A Randomized Controlled Trial
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?
Read more
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)
Read the detailed description
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.
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.
- Being tested
- Digital exercise program, Personal coaching for physical activity promotion
- Keywords
- Total Hip Arthroplasty, Physical Activity, Older Adults, Digital Intervention, Physical Exercise, Coaching, Patient Education, Postoperative Care, Ambulatory Monitoring, Behavior Change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital exercise programBehavioural
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 for physical activity promotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital exercise program with personal coaching (Intervention Group 1) | Experimental | Participants receive a tablet with the pre-installed training app KOKU, which delivers a 12-week standardized digital home-based strength and balance program. Participants are introduced to KOKU during an initial home visit and are encouraged to complete the program independently over the subsequent 12 weeks. In addition, they receive three individualized coaching sessions via video calls on the tablet during this period. To support self-monitoring and provide feedback on PA behavior - integrated into the BCTs used in the personal coaching - participants also receive a low-cost, easy-to-use wrist-worn activity tracker along with instructions on its use during the initial home visit. Receives: Behavioral: Digital exercise program; Behavioral: Personal coaching for physical activity promotion |
| Digital exercise program without personal coaching (Intervention Group 2) | Experimental | Participants receive a tablet with the pre-installed training app KOKU, which delivers a 12-week standardized digital home-based strength and balance program. Participants are introduced to KOKU during an initial home visit and are encouraged to complete the program independently over the subsequent 12 weeks. No personal coaching is provided. Receives: Behavioral: Digital exercise program |
| Usual care (Control Group) | No intervention | Participants receive a tablet without access to the KOKU app and do not receive any personal coaching sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily 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.
Measured: 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.
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (c)
30-Second Chair Stand Test
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (d)
4-Meter Gait Speed Test
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Hip pain and function
Oxford Hip Score
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Life-space mobility
University of Alabama at Birmingham Life-Space Assessment
Measured: 1 week preoperatively (T1), and 6 months postoperatively (T3)
Concerns about falling
Short Falls Efficacy Scale-International
Measured: 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
Measured: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Self-perceived health status
EuroQol Visual Analogue Scale
Measured: 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)
Measured: 6 weeks postoperatively (T2) and 6 months postoperatively (T3)
Self-reported physical activity level
University of California Los Angeles Activity Score
Measured: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Conscientiousness
Conscientiousness dimension of Big Five Inventory-2
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Exercise motivation
Behavioural Regulation in Exercise Questionnaire
Measured: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Rate of falls
Daily fall calendars
Measured: From 6 weeks postoperatively (T2) to 6 months postoperatively (T3)
Executive functioning
Trail Making Test A \& B
Measured: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Health-related resource use
Questionnaire for Health-Related Resource Use in an Elderly Population
Measured: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, assessor-blinded, three-arm parallel trial with a 12-week intervention period: (1) digital exercise program with personal coaching, (2) digital exercise program without personal coaching, and (3) control group (usual care).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Reiner, University Hospital Heidelberg
- Investigators
- Tobias Reiner, PhD, MD, Principal investigator, Department of Orthopaedics, Heidelberg University HospitalChristian Werner, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135843
- Sponsor's protocol ID
- S-324/2024
- Other IDs
- 1DH2411155
- Acronym
- iPATH
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In line with the principles of open science, anonymized individual participant data from the iPATH trial will be made available to qualified researchers after the primary evaluation has been completed and published. Data will be shared in a format that does not permit identification of individual participants and in full compliance with applicable data protection regulations (e.g., General Data Protection Regulation, EU data protection standards). Access to the data will be provided via a recognized open-access repository and require a formal application with a description of the proposed research project.
Publications
Buchner T, Knopf S, Haas AS, Eckert T, Fritz R, Merling M, Sander A, Klose C, Walker T, Bauer JM, Becker C, Werner C, Reiner T. Digital home-based physical activity promotion for older adults after total hip arthroplasty: protocol for the randomized controlled iPATH trial. BMC Geriatr. 2026 Jan 24;26(1):102. doi: 10.1186/s12877-026-07013-9.
PubMed 41578219
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPATH - Digital Home-Based Training for Physical Activity Promotion in Older Adults After Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07135843
- Acronym / sponsor ID
- iPATH / S-324/2024
- Keywords
- Total Hip Arthroplasty, Physical Activity, Older Adults, Digital Intervention, Physical Exercise, Coaching, Patient Education, Postoperative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled, assessor-blinded, three-arm parallel trial with a 12-week intervention period: (1) digital exercise program with personal coaching, (2) digital exercise program without personal coaching, and (3) control group (usual care).
| Arm | Type | Receives |
|---|---|---|
| Digital exercise program with personal coaching (Intervention Group 1) | Experimental | Behavioral: Digital exercise program, Behavioral: Personal coaching for physical activity promotionParticipants receive a tablet with the pre-installed training app KOKU, which delivers a 12-week standardized digital home-based strength and balance program. Participants are introduced to KOKU during an initial home visit and are encouraged to complete the program independently over the subsequent 12 weeks. In addition, they receive three individualized coaching sessions via video calls on the tablet during this period. To support self-monitoring and provide feedback on PA behavior - integrated into the BCTs used in the personal coaching - participants also receive a low-cost, easy-to-use wrist-worn activity tracker along with instructions on its use during the initial home visit. |
| Digital exercise program without personal coaching (Intervention Group 2) | Experimental | Behavioral: Digital exercise programParticipants receive a tablet with the pre-installed training app KOKU, which delivers a 12-week standardized digital home-based strength and balance program. Participants are introduced to KOKU during an initial home visit and are encouraged to complete the program independently over the subsequent 12 weeks. No personal coaching is provided. |
| Usual care (Control Group) | No intervention | –Participants receive a tablet without access to the KOKU app and do not receive any personal coaching sessions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital exercise programKOKU 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. | Behavioural | Digital exercise program with personal coaching (Intervention Group 1), Digital exercise program without personal coaching (Intervention Group 2) |
| Personal coaching for physical activity promotionPersonal 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. | Behavioural | Digital exercise program with personal coaching (Intervention Group 1) |
Primary outcome
Daily step count
Time frame: 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
Time frame: 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.
24 secondary outcomes
Daily walking duration
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily walking bout count
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life walking bout duration
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life walking speed
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life stride length
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life stride duration
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life cadence
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Daily-life walking variability
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (a)
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (b)
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (c)
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Physical capacity (d)
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Hip pain and function
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Life-space mobility
Time frame: 1 week preoperatively (T1), and 6 months postoperatively (T3)
Concerns about falling
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Health-related quality of life
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Self-perceived health status
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Change in self-perceived walking ability
Time frame: 6 weeks postoperatively (T2) and 6 months postoperatively (T3)
Self-reported physical activity level
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Conscientiousness
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Exercise motivation
Time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Rate of falls
Time frame: From 6 weeks postoperatively (T2) to 6 months postoperatively (T3)
Executive functioning
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Health-related resource use
Time frame: 1 week preoperatively (T1) and 6 months postoperatively (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 41578219Buchner T, Knopf S, Haas AS, Eckert T, Fritz R, Merling M, Sander A, Klose C, Walker T, Bauer JM, Becker C, Werner C, Reiner T. Digital home-based physical activity promotion for older adults after total hip arthroplasty: protocol for the randomized controlled iPATH trial. BMC Geriatr. 2026 Jan 24;26(1):102. doi: 10.1186/s12877-026-07013-9.
- Individual participant dataSharing planned: Yes. In line with the principles of open science, anonymized individual participant data from the iPATH trial will be made available to qualified researchers after the primary evaluation has been completed and published. Data will be shared in a format that does not permit identification of individual participants and in full compliance with applicable data protection regulations (e.g., General Data Protection Regulation, EU data protection standards). Access to the data will be provided via a recognized open-access repository and require a formal application with a description of the proposed research project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Reiner, PhD, MD principal investigator
Department of Orthopaedics, Heidelberg University Hospital
Christian Werner, PhD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital exercise program and Personal coaching for physical activity promotion in people with Total Hip Arthroplasty (THA) and Older Adults (65 Years and Older), run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Eckert, PhD (+49 (0)6221 319 1562, tobias.eckert@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily step count (time frame: 1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07135843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.