Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty

NCT ID: NCT04471532

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2024-02-02

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.

Conditions

Arthroplasty, Replacement, Hip

Study Design

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

Study Groups

Behavior change intervention

A 3-month behavior change intervention i.e. one initial, face-to-face, physical activity counselling and two telephone-assisted counselling.

Group Type: EXPERIMENTAL

Behavior change intervention

Intervention Type: BEHAVIORAL

It is a 3-month, multimodal, minimal contact, pedometer-driven, behavior change intervention to promote and support physical activity, that is initiated 3 months after THA. There is one initial, physiotherapist-led, face-to-face, physical activity counselling including 1) a brief motivational interviewing regarding physical activity, 2) patient education regarding physical activity after THA including recommendations and safety based on an "orthopedic surgeon guided" video and leaflet, 3) handling out pedometer and educational material i.e. a practice-oriented leaflet with advice on how to use a pedometer, a step-calendar and goal setting as well as strategies to incorporate physical activity into daily life. This initial counselling is followed by two, physiotherapist-led, telephone-assisted counselling after respectively three and seven weeks.

Control

No attention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavior change intervention

It is a 3-month, multimodal, minimal contact, pedometer-driven, behavior change intervention to promote and support physical activity, that is initiated 3 months after THA. There is one initial, physiotherapist-led, face-to-face, physical activity counselling including 1) a brief motivational interviewing regarding physical activity, 2) patient education regarding physical activity after THA including recommendations and safety based on an "orthopedic surgeon guided" video and leaflet, 3) handling out pedometer and educational material i.e. a practice-oriented leaflet with advice on how to use a pedometer, a step-calendar and goal setting as well as strategies to incorporate physical activity into daily life. This initial counselling is followed by two, physiotherapist-led, telephone-assisted counselling after respectively three and seven weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Helsefonden, Denmark

UNKNOWN

Sponsor Role: collaborator

Hartmann Fonden

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Theresa Bieler

Research Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Bieler, PT, PhD

Role: STUDY_DIRECTOR

Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy

Locations

Bispebjerg Hospital, Department of Physical & Occupational Therapy

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 35964101 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H-19050820

Identifier Type: -

Identifier Source: org_study_id