Bispebjerg Hospital, Department of Physical & Occupational Therapy
Copenhagen, 2400, Denmark
NCT Number: NCT04471532
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2400, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months after THA
The mean number of steps completed per day assessed by an accelerometer during a 7-day period.
Time frame: 6 months after THA
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Time frame: 6 months after THA
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.
Time frame: 6 months after THA
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.
Time frame: 6 months after THA
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.
Time frame: 6 months after THA
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.
Time frame: 6 months after THA
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.
Time frame: 6 months after THA
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".
Time frame: 6 months after THA
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Time frame: 6 and 12 months after THA
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Time frame: 6 and 12 months after THA
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)
Time frame: 12 months after THA
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Time frame: 12 months after THA
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Time frame: 12 months after THA
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.
Time frame: 12 months after THA
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.
Time frame: 12 months after THA
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.
Time frame: 12 months after THA
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.
Time frame: 12 months after THA
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.
Time frame: 12 months after THA
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".
Time frame: 6 and 12 months after THA
Assessed by the Physical Activity Scale for the Elderly (PASE) that assesses the level of physical activity (occupational, household and leisure activities) over a one-week period. The score range is 0-400 or more (lowest to highest physical activity-level).
Time frame: 6 and 12 months after THA
Assessed by a question "How physically active are you now?" from the Copenhagen City Heart Study (level 1-4; 1 = almost entirely sedentary, 2 = light physical activity (PA) for 2-4 h per week, 3 = light PA >4 h per week or more vigorous PA for 2-4 h per week, 4 = more vigorous PA >4 h per week or regular heavy exercise or competitive sports several times per week).
Time frame: 6 and 12 months after THA
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 and a separate 20cm visual analog scale with anchors being: 0="worst imaginable health state"; 100="best imaginable health state".
Time frame: 6 and 12 months after THA
Assessed by the exercise self-efficacy scale, which consists of 5 questions concerning the confidence of perceived ability to participate in exercise despite barriers as bad mood, bad weather, tiredness or lack of time (total score range, 5-25, worst to best).
Time frame: 6 and 12 months after THA
Assessed in conjunction with the stair-climbing test. After a practice trial, the participants are asked to rate their level of certainty that they can complete the stair-climbing task 2, 4, 6, 8, and 10 times without stopping (total score 0-100 (worst to best)).
Time frame: 6 and 12 months after THA
Assessed by the Outcome expectancy for exercise scale (OEE-2), an interviewer administered questionnaire with 13 questions regarding both positive and negative expectations associated with exercise. A positive outcome expectancy subscale, a negative outcome expectancy subscale and a total score can be calculated (more positive outcome expectations for exercise with higher score).
Time frame: 6 and 12 months after THA
Assessed by the Hip disability and Osteoarthritis Outcome Score (HOOS), the other symptoms subscale. The last week is taken into consideration when answering the 5 questions (5 Likert boxes) included in this subscale. A normalized score (0-100, worst to best) can be calculated.
Time frame: 6 and 12 months after THA
Assessed by the Hip disability and Osteoarthritis Outcome Score (HOOS), the function in sport and recreation subscale. The last week is taken into consideration when answering the 4 questions (5 Likert boxes) included in this subscale. A normalized score (0-100, worst to best) can be calculated.
Time frame: 6 and 12 months after THA
Assessed by the Hip disability and Osteoarthritis Outcome Score (HOOS), the hip-related quality of life subscale. The last week is taken into consideration when answering the 4 questions (5 Likert boxes) included in this subscale. A normalized score (0-100, worst to best) can be calculated.
Time frame: 12 months after THA
The mean number of steps completed per day assessed with an accelerometer during a 7-day period.
Bispebjerg Hospital
Other
Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty (PANORAMA). A Pragmatic, Randomized, Controlled, Trial.
Acronym: PANORAMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01878175
Arthroplasty, Replacement, Hip, Behavior
Durham, North Carolina, United States
View Trial DetailsNCT06102811
Arthroplasty, Replacement, Hip
Toronto, Ontario, Canada
View Trial DetailsNCT07431138
Arthroplasty, Replacement, Hip, Postoperative Evaluation
Ankara, Yenimahalle, Turkey (Türkiye)
View Trial DetailsNCT02520544
Arthroplasty, Replacement, Hip
Antwerp, Belgium
View Trial Details