Arthroplasty, Replacement, HipPANORAMANCT04471532
Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty
A study testing Behavior change intervention in people with Arthroplasty, Replacement, Hip, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Behavior change intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Aug 2020to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Home dwelling, independent and self-reliant adults
- Patients who has received primary total hip arthroplasty because of hip osteoarthritis
- Informed consent to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Physical & Occupational Therapy
Copenhagen, 2400
About this study
Official title: Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty (PANORAMA). A Pragmatic, Randomized, Controlled, Trial.
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.
Read more
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
- Being tested
- Behavior change intervention
- Keywords
- Exercise, Motivation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior change interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavior change intervention |
| Control | No intervention | No attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after THA
Secondary outcomes (10)
The number of participants that complete ≥ 10,000 steps per day
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Measured: 6 months after THA
Change from baseline in the 6-minute walk test
The 6-minute walk test is a performance-based test of physical function which covers the domain ability to walk over longer distances. It is also a proxy measure of endurance/aerobic capacity. This test measures the walking distance completed in 6 minutes on a 30-m flat course. The participant is instructed to walk as far as possible in 6 minutes. The 6-minute walk test is included in a set of performance-based test recommended by the Osteoarthritis Research Society International that represents typical activities relevant to individuals following total joint arthroplasties.
Measured: 6 months after THA
Change from baseline in the 30-s chair-stand test
The 30-s chair-stand test is a performance-based test of physical function which covers the domains: sitting and getting in/out of a seated position. It is also a proxy measure for assessing lower body muscle strength and power. This test measures number of chair stands completed in 30 seconds. The participant is instructed to complete as many chair stands as possible in 30 seconds with arms across the chest. The 30-s chair-stand test is included in a set of performance-based test recommended by the Osteoarthritis Research Society International that represents typical activities relevant to individuals following total joint arthroplasties.
Measured: 6 months after THA
Change from baseline in the stair-climb test
The stair-climb test is a performance-based test of physical function which covers the domains: mobility and climbing. It is also a proxy measure for assessing lower extremity muscle strength and power and balance. This test measures the time (best of two trials) to ascend and descend a flight of 10 steps. The participant is instructed to ascend and descend the flight of stairs as fast as possible. The stair-climb test is included in a set of performance-based test recommended by the Osteoarthritis Research Society International that represents typical activities relevant to individuals following total joint arthroplasties.
Measured: 6 months after THA
Change from baseline in self-reported physical function
Assessed by the Hip disability and Osteoarthritis Outcome Score (HOOS), the function in daily living (ADL) subscale. The last week is taken into consideration when answering the 17 questions (5 Likert boxes) included in this subscale. A normalized score (0-100, worst to best) can be calculated.
Measured: 6 months after THA
Change from baseline in hip pain
Assessed by the Hip disability and Osteoarthritis Outcome Score (HOOS), the pain subscale. The last week is taken into consideration when answering the 10 questions (5 Likert boxes) included in this subscale. A normalized score (0-100, worst to best) can be calculated.
Measured: 6 months after THA
Change from baseline in the patients' assessment of global perceived effect
The participants will be asked to compare their current global wellbeing with the pre-surgery state on a 200 mm visual analog scale with anchors being: -100 = "Much worse"; 0 = "No changes"; 100 = "Much better".
Measured: 6 months after THA
The mean number of steps per day
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Measured: 6 months after THA
The number of participants that complete ≥ 5,000 steps per day
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Measured: 6 and 12 months after THA
Health-related quality of life
Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-3L), a generic instrument with 5 questions that comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels: no problems, some problems, and extreme problems, where each dimension is assigned a score from 1 to 3, which can be converted into a single summary index value (based on the Danish EQ-5D Time Trade-Off (TTO) value set; 1 corresponds to the best possible health status, <0 represents the worst possible health status)
Measured: 6 and 12 months after THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start31 Aug 2020
- Primary completion3 Jul 2023
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Helsefonden, Denmark, Hartmann Fonden
- Responsible party
- Principal investigator, Theresa Bieler, Bispebjerg Hospital
- Investigators
- Theresa Bieler, PT, PhD, Study director, Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471532
- Sponsor's protocol ID
- H-19050820
- Acronym
- PANORAMA
- Status last verified
- Feb 2024
- First submitted
- 7 Jul 2020
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Proposal for data use should be addressed to theresa.bieler@regionh.dk. Data access in Denmark is under very strict juristic data protection law. Any possible access or sharing demands a part application to: The Danish Data Protection Agency and The Ethics Committee of the Capital Region. Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process and a prolonged process must be expected.
Publications
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.
PubMed 35964101
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty (PANORAMA). A Pragmatic, Randomized, Controlled, Trial.
- ClinicalTrials.gov ID
- NCT04471532
- Acronym / sponsor ID
- PANORAMA / H-19050820
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Exercise, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Helsefonden, Denmark, Hartmann Fonden
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavior change intervention | Experimental | Behavioral: Behavior change interventionA 3-month behavior change intervention i.e. one initial, face-to-face, physical activity counselling and two telephone-assisted counselling. |
| Control | No intervention | –No attention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Home dwelling, independent and self-reliant adults
- Patients who has received primary total hip arthroplasty because of hip osteoarthritis
- Informed consent to participate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior change interventionIt 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. | Behavioural | Behavior change intervention |
Primary outcome
The number of participants that complete ≥ 8,000 steps per day
Time frame: 6 months after THA
The mean number of steps completed per day assessed by an accelerometer during a 7-day period.
10 secondary outcomes
The number of participants that complete ≥ 10,000 steps per day
Time frame: 6 months after THA
Change from baseline in the 6-minute walk test
Time frame: 6 months after THA
Change from baseline in the 30-s chair-stand test
Time frame: 6 months after THA
Change from baseline in the stair-climb test
Time frame: 6 months after THA
Change from baseline in self-reported physical function
Time frame: 6 months after THA
Change from baseline in hip pain
Time frame: 6 months after THA
Change from baseline in the patients' assessment of global perceived effect
Time frame: 6 months after THA
The mean number of steps per day
Time frame: 6 months after THA
The number of participants that complete ≥ 5,000 steps per day
Time frame: 6 and 12 months after THA
Health-related quality of life
Time frame: 6 and 12 months after THA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 35964101Bieler 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.
- Individual participant dataSharing planned: Yes. Proposal for data use should be addressed to theresa.bieler@regionh.dk. Data access in Denmark is under very strict juristic data protection law. Any possible access or sharing demands a part application to: The Danish Data Protection Agency and The Ethics Committee of the Capital Region. Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process and a prolonged process must be expected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Bieler, PT, PhD study director
Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior change intervention in people with Arthroplasty, Replacement, Hip, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants that complete ≥ 8,000 steps per day (time frame: 6 months after THA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.