Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty

NCT ID: NCT07135843

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-01-31

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)

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:

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.

Conditions

Total Hip Arthroplasty (THA); Older Adults (65 Years and Older)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Digital exercise program with personal coaching (Intervention Group 1)

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.

Group Type: EXPERIMENTAL

Digital exercise program

Intervention Type: BEHAVIORAL

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 promotion

Intervention Type: BEHAVIORAL

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.

Digital exercise program without personal coaching (Intervention Group 2)

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.

Group Type: EXPERIMENTAL

Digital exercise program

Intervention Type: BEHAVIORAL

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.

Usual care (Control Group)

Participants receive a tablet without access to the KOKU app and do not receive any personal coaching sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital exercise program

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.

Intervention Type: BEHAVIORAL

Personal coaching for physical activity promotion

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geriatric Center, Heidelberg University

UNKNOWN

Sponsor Role: collaborator

Heidelberg University - Institute of Medical Biometry (IMBI)

UNKNOWN

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Tobias Reiner

Priv.-Doz. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Reiner, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, Heidelberg University Hospital

Christian Werner, PhD

Role: PRINCIPAL_INVESTIGATOR

Geriatric Center, Heidelberg University

Locations

Department of Orthopaedics, Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tobias Eckert, PhD

Role: CONTACT

tobias.eckert@med.uni-heidelberg.de

+49 (0)6221 319 1562

Christian Werner, PhD

Role: CONTACT

christian.werner@med.uni-heidelberg.de

+49 (0)6221 319 1759

Facility Contacts

Tobias Reiner, Priv.-Doz. Dr. med.

Role: primary

tobias.reiner@med.uni-heidelberg.de

+49 (0)6221 25000

Other Identifiers

1DH2411155

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S-324/2024

Identifier Type: -

Identifier Source: org_study_id