Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty
iPATH
iPATH - Digital Home-Based Training for Physical Activity Promotion in Older Adults After Total Hip Arthroplasty: A Randomized Controlled Trial
2 other identifiers
interventional
213
1 country
1
Brief 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). 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
September 2, 2025
August 1, 2025
2.3 years
August 7, 2025
August 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)
Secondary Outcomes (24)
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)
- +19 more secondary outcomes
Other Outcomes (6)
Adverse events
6 weeks postoperatively (T2) and 6 months postoperatively (T3); interim events recorded as reported.
Training adherence (a)
6 months postoperatively (T3)
Training adherence (b)
6 months postoperatively (T3)
- +3 more other outcomes
Study Arms (3)
Digital exercise program with personal coaching (Intervention Group 1)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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 INTERVENTIONParticipants receive a tablet without access to the KOKU app and do not receive any personal coaching sessions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopaedics, Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69118, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Reiner, PhD, MD
Department of Orthopaedics, Heidelberg University Hospital
- PRINCIPAL INVESTIGATOR
Christian Werner, PhD
Geriatric Center, Heidelberg University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Biostatistician responsible for data analysis remains blinded until the database is locked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz. Dr. med.
Study Record Dates
First Submitted
August 7, 2025
First Posted
August 22, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Anonymized individual participant data (IPD) will be made available approximately 6 months after publication of the primary evaluation results and will remain accessible without a predefined end date. The study protocol will be submitted for publication in an open-access, peer-reviewed journal before the last patient is enrolled. The statistical analysis plan (SAP) will be published alongside the primary evaluation results.
- Access Criteria
- Access will be granted to qualified researchers affiliated with recognized academic or research institutions. A formal application including a research proposal is required, and applicants must agree to a data use agreement ensuring ethical use and compliance with EU data protection regulations. Approved applicants will access the data via the designated open-access repository.
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.