Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty

NCT04471532 | Completed

• 1 other identifier: H-19050820
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Motivation

Outcome Measures

Primary Outcomes (1)

• The number of participants that complete ≥ 8,000 steps per day

  The mean number of steps completed per day assessed by an accelerometer during a 7-day period.

  6 months after THA

Secondary Outcomes (10)

• The number of participants that complete ≥ 10,000 steps per day

  6 months after THA

• Change from baseline in the 6-minute walk test

  6 months after THA

• Change from baseline in the 30-s chair-stand test

  6 months after THA

• Change from baseline in the stair-climb test

  6 months after THA

• Change from baseline in self-reported physical function

  6 months after THA

Other Outcomes (18)

• The number of participants that complete ≥ 8,000 steps per day

  12 months after THA

• The number of participants that complete ≥ 10,000 steps per day

  12 months after THA

• Change from baseline in the 6-minute walk test

  12 months after THA

Study Arms (2)

Behavior change intervention

EXPERIMENTAL

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

Behavioral: Behavior change intervention

Control

NO INTERVENTION

No attention

Interventions

Behavior change intervention 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.

Behavior change intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• TrygFonden, Denmark: collaborator
• Helsefonden, Denmark: collaborator
• Hartmann Fonden: collaborator

Study Sites (1)

Bispebjerg Hospital, Department of Physical & Occupational Therapy

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35964101 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Theresa Bieler, PT, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcome assessors will be blinded to group allocation and previous results and the participants are requested not to disclose their allocation when outcomes are assessed 6 and 12 months after surgery. The biostatistician who perform the data analyses and validate the results will also be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Therapist

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 15, 2020
• Study Start: August 31, 2020
• Primary Completion: July 3, 2023
• Study Completion: February 2, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Statistical Analysis Plan (SAP) available from 19.12.23, Analytic Code unresolved
• Access Criteria: Please read plan description

Locations

DK (1)