NCT07135843 Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty
| NCT ID | NCT07135843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heidelberg University |
| Condition | Total Hip Arthroplasty (THA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 213 participants |
| Start Date | 2025-09 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 213 participants in total. It began in 2025-09 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Tobias Reiner, PhD, MD
PRINCIPAL INVESTIGATOR
Department of Orthopaedics, Heidelberg University Hospital
Frequently Asked Questions
Who can join the NCT07135843 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Total Hip Arthroplasty (THA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07135843 currently recruiting?
Yes, NCT07135843 is actively recruiting participants. Contact the research team at tobias.eckert@med.uni-heidelberg.de for enrollment information.
Where is the NCT07135843 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT07135843 clinical trial?
NCT07135843 is sponsored by Heidelberg University. The principal investigator is Tobias Reiner, PhD, MD at Department of Orthopaedics, Heidelberg University Hospital. The trial plans to enroll 213 participants.