Clinical trial NCT04471532: Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty
Official title: Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty (PANORAMA). A Pragmatic, Randomized, Controlled, Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Exercise
Motivation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Helsefonden, Denmark
name: Hartmann Fonden
First posted: 2020-07-15
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pragmatic, randomized, controlled, assessor- and statistician- blinded trial with two parallel groups; an intervention group receiving a behavior change intervention and a control group receiving no intervention.
Primary purpose: TREATMENT

Brief summary: Total hip arthroplasty (THA) is considered an efficacious procedure for relieving pain and disability in patients with hip osteoarthritis. However, 6-12 months post-surgery physical activity level is unchanged compared to pre-surgery and still considerably lower than that of healthy peers. Increasing physical activity after THA may enhance the outcome of the THA because a graded relationship between physical activity level and functional performance has been documented. Six-8 months after THA physical function is only recovered to about 80% of that of healthy peers and older adults still seem to be at increased risk of frailty. Furthermore, these patients continue to impose higher healthcare costs than an age- and sex-matched reference population which potentially could be related to the functional status that is not completely regained. Finally, patients with hip osteoarthritis can have extensive comorbidity thus increasing physical activity after THA could be a simple and relatively inexpensive method for improving general health, which in turn may decrease healthcare costs.

The reasons for the lack of increase in physical activity despite increased capability after THA are unknown but it may be related to the sedentary behavior adopted by the patients prior to surgery and uncertainty. A systematic review has illuminated that patient-reported barriers to engaging in physical activity after THA are largely related to limited or inadequate information or education culminating in uncertainty about 'doing the right thing' for both the individual's recovery and the longevity of the joint replacement.

Few studies have investigated the effects of specific interventions to increase physical activity after THA. Promising results have been shown from physical activity sensors in combination with e.g. goal setting. None of these studies have addressed the patient-reported barriers to physical activity regarding uncertainty and limited education.

This trial aims to investigate the effect of adding a pedometer-driven, behavior change intervention to usual rehabilitation care 3 months after THA to increase physical activity compared to usual rehabilitation care alone (control). Outcomes are taken 3 (baseline), 6 (after the intervention period) and 12 months after THA (follow-up).

Hypothesis: the behavior change intervention will increase the proportion that completes ≥8,000 steps per day 6-month post-surgery to 50% versus 30% in the control group.


Eligibility criteria: Inclusion Criteria:

* Home dwelling, independent and self-reliant adults
* Patients who has received primary total hip arthroplasty because of hip osteoarthritis
* Informed consent to participate

Exclusion Criteria:

* Planned joint arthroplasty in the lower extremities within the next 6 months
* Patients who are unable to read, understand and speak Danish
* Complications in relation to total hip arthroplasty e.g. dislocation, fracture or infection
* Any other condition that in the opinion of the investigator makes a potential participant unfit for participation

Primary outcomes:
measure: The number of participants that complete ≥ 8,000 steps per day
timeFrame: 6 months after THA
Secondary outcomes:
measure: The number of participants that complete ≥ 10,000 steps per day
timeFrame: 6 months after THA
measure: Change from baseline in the 6-minute walk test
timeFrame: 6 months after THA
measure: Change from baseline in the 30-s chair-stand test
timeFrame: 6 months after THA
measure: Change from baseline in the stair-climb test
timeFrame: 6 months after THA
measure: Change from baseline in self-reported physical function
timeFrame: 6 months after THA
measure: Change from baseline in hip pain
timeFrame: 6 months after THA
measure: Change from baseline in the patients' assessment of global perceived effect
timeFrame: 6 months after THA
measure: The mean number of steps per day
timeFrame: 6 months after THA
measure: The number of participants that complete ≥ 5,000 steps per day
timeFrame: 6 and 12 months after THA
measure: Health-related quality of life
timeFrame: 6 and 12 months after THA
Other outcomes:
measure: The number of participants that complete ≥ 8,000 steps per day
timeFrame: 12 months after THA
measure: The number of participants that complete ≥ 10,000 steps per day
timeFrame: 12 months after THA
measure: Change from baseline in the 6-minute walk test
timeFrame: 12 months after THA
measure: Change from baseline in the 30-s chair-stand test
timeFrame: 12 months after THA
measure: Change from baseline in the stair-climb test
timeFrame: 12 months after THA
measure: Change from baseline in self-reported physical function
timeFrame: 12 months after THA
measure: Change from baseline in hip pain
timeFrame: 12 months after THA
measure: Change from baseline in the patients' assessment of global perceived effect
timeFrame: 12 months after THA
measure: Change from baseline in self-reported physical activity
timeFrame: 6 and 12 months after THA
measure: Change from baseline in self-reported physical activity level
timeFrame: 6 and 12 months after THA
measure: Change from baseline in Health-related quality of life
timeFrame: 6 and 12 months after THA
measure: Change from baseline in self-efficacy for physical activity
timeFrame: 6 and 12 months after THA
measure: Change from baseline in task-specific self-efficacy
timeFrame: 6 and 12 months after THA
measure: Change from baseline in outcome expectancy for physical activity
timeFrame: 6 and 12 months after THA
measure: Change from baseline in symptoms (other than pain)
timeFrame: 6 and 12 months after THA
measure: Change from baseline in function in sport and recreation
timeFrame: 6 and 12 months after THA
measure: Change from baseline in hip-related quality of life
timeFrame: 6 and 12 months after THA
measure: The mean number of steps per day
timeFrame: 12 months after THA
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical & Occupational Therapy
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy
name: Theresa Bieler, PT, PhD
role: STUDY_DIRECTOR
References:
citation: Bieler T, Magnusson SP, Siersma V, Rinaldo M, Schmiegelow MT, Beck T, Krifa AM, Kjaer BH, Palm H, Midtgaard J. Effectiveness of promotion and support for physical activity maintenance post total hip arthroplasty-study protocol for a pragmatic, assessor-blinded, randomized controlled trial (the PANORAMA trial). Trials. 2022 Aug 13;23(1):647. doi: 10.1186/s13063-022-06610-4.