Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHeidelberg University
About this 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?
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital exercise program
BehavioralKOKU 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
BehavioralPersonal 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.
Treatment groups
213 Participants
are divided into 3 treatment groupsGroup A: Digital exercise program with personal coaching (Intervention Group 1)Experimental treatment 2 interventions
Group B: Digital exercise program without personal coaching (Intervention Group 2)Experimental treatment 1 intervention
Group C: Usual care (Control Group)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 week preoperatively (T1), 6 weeks postoperatively (T2), and 6 months postoperatively (T3)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
Adverse events
Frequency, type, severity, and relation to the intervention of participant-reported (serious) adverse adverse events will be documented using standardized case report forms.
Time frame
6 weeks postoperatively (T2) and 6 months postoperatively (T3); interim events recorded as reported.2
Training adherence (a)
Exercise Adherence Rating Scale
Time frame
6 months postoperatively (T3)3
Training adherence (b)
Usage data of the training app (KOKU) retrieved from the tablet
Time frame
6 months postoperatively (T3)4
Intervention acceptability (a)
Theoretical Framework of Acceptability Questionnaire (range: 7-35 points, higher scores indicate higher acceptability)
Time frame
6 months postoperatively (T3)Sponsors and contacts
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Heidelberg University
Lead sponsor
University Hospital Heidelberg
Sponsor institution
Source ClinicalTrials.gov