Step Promotion for Osteoarthritis

(STOP Trial)

Overseen By Caroline Lisee, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Georgia

Disqualifiers: Acl revision, Multiple ligament surgery, Fracture, Joint diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

56 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Adaptive Daily Step Promotion for osteoarthritis?

Research shows that a treatment approach called behavioural graded activity, which encourages gradual increases in physical activity, leads to better exercise adherence and more physical activity in people with osteoarthritis compared to usual care. This suggests that promoting daily steps could be effective for managing osteoarthritis. ^{1 2 3 4 5}

How does the Step Promotion treatment for osteoarthritis differ from other treatments?

The Step Promotion treatment for osteoarthritis is unique because it uses a smartphone app to set adaptive step goals and rewards, encouraging increased physical activity through walking. This approach is different from traditional treatments as it focuses on behavior change and personalized goals to improve mobility and health. ^{6 7 8 9 10}

What is the purpose of this trial?

Optimal knee joint loading, which refers to the forces acting on the knee caused by daily activities such as daily steps, plays an essential role in maintaining knee articular cartilage health and reducing the risk of osteoarthritis (OA). After anterior cruciate ligament reconstruction (ACLR), individuals take fewer daily steps as compared to uninjured controls resulting in insufficient knee joint loading to joint tissues, but it is unclear how changes in daily steps impact knee joint cartilage health in OA development. Therefore, the overall single arm, longitudinal pre-test post-test study objective is to determine the mechanistic links between knee joint loading as measured by daily steps and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain.

Research Team

Caroline Lisee, PhD

Principal Investigator

University of Georgia

Eligibility Criteria

This trial is for individuals who had ACL reconstruction surgery 6-24 months ago, are finished with physical therapy, can do unrestricted activities, and take fewer than 7,000 steps daily. They must own a smartphone and not plan to start any new knee therapies during the study. It's not for those with previous ACL graft injuries or other joint diseases in the knees, pregnant women or those planning pregnancy soon, people with BMI ≥ 36 kg/m2, non-English speakers, or certain medical conditions.

Inclusion Criteria

Provision of signed and dated informed consent form

I had ACL surgery between 6 to 24 months ago.

My doctor says I can do any activity without restrictions.

Exclusion Criteria

Pregnant or plans to become pregnant over next 4 months

Body mass index (BMI) ≥ 36 kg/m2

Pacemaker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment including MRI and physical activity monitoring

1 week

1 visit (in-person)

Intervention

Participants engage in a 16-week daily step promotion intervention to increase daily steps

16 weeks

Regular monitoring (virtual)

Post-Intervention Assessment

Participants undergo post-intervention assessment including MRI and physical activity monitoring

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Adaptive Daily Step Promotion

Trial Overview The study aims to understand how daily walking affects knee cartilage health after ACL surgery by using MRI scans. Participants will track their steps to see if low activity levels lead to weaker cartilage. The hypothesis is that fewer daily steps result in poorer knee cartilage condition.

Participant Groups

Group I: Interventional Group Experimental Treatment 1 Intervention

Participants who meet study criteria and are enrolled in adaptive daily step promotion intervention

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

In a study of 51 participants who underwent total knee replacement, younger age was found to be a significant predictor of adherence to a step count intervention, with 47% of participants exceeding their step goals.

While higher patient activation and technology self-efficacy initially appeared to correlate with better adherence, these factors were not significant after adjusting for age, suggesting that age may be a more critical factor in adherence to post-surgery rehabilitation activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Adherence to a Step Count Intervention Following Total Knee Replacement: An Exploratory Cohort Study. Duong, V., Dennis, S., Ferreira, ML., et al.[2022]

In a study of 122 patients with advanced hip osteoarthritis, using a Fitbit to track daily steps revealed an average of 5721 steps per day, indicating a measurable level of physical activity.

There was a significant positive correlation between the number of steps taken and patient-reported outcomes, suggesting that wearable technology can effectively assess physical activity levels and their impact on health in hip OA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between hip osteoarthritis and the level of physical activity as measured by wearable technology and patient-reported questionnaires. Morcos, MW., Teeter, MG., Somerville, LE., et al.[2022]

In a study involving 200 patients with hip and/or knee osteoarthritis, those who participated in 18 sessions of behavioral graded activity showed significantly higher exercise adherence compared to those receiving usual care, both at 13 weeks and 65 weeks.

The experimental group also had a greater number of participants meeting physical activity recommendations at both time points, indicating that behavioral graded activity is more effective in promoting long-term physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial. Pisters, MF., Veenhof, C., de Bakker, DH., et al.[2019]

The study analyzed data from three phase III clinical trials involving a total of 4,480 patients with moderate-to-severe osteoarthritis (OA) to define meaningful within-patient change (MWPC) in the WOMAC index, which measures pain, physical function, and stiffness.

The established MWPC values for WOMAC domains ranged from 0.84-1.16 on a 0-10 scale, indicating the amount of change needed for patients to feel a significant difference in their OA symptoms, which can help in assessing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. Conaghan, PG., Dworkin, RH., Schnitzer, TJ., et al.[2022]

A feasibility study involving 26 participants with knee osteoarthritis demonstrated that smartwatches can effectively track daily pain levels and step counts in real time, providing valuable data on day-to-day variability in pain.

Participants with fluctuating pain levels had significantly lower average step counts compared to those with sustained high or low pain, suggesting a potential link between pain variability and physical activity that warrants further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Day-to-day variability of knee pain and the relationship with physical activity in people with knee osteoarthritis: an observational, feasibility study using consumer smartwatches. Vivekanantham, A., Selby, D., Lunt, M., et al.[2023]

A new low-technology measure of exercise capacity was developed and tested on 158 employed African American women, showing that it correctly categorized 79.33% of participants based on their exercise tolerance, significantly outperforming average daily steps (ADS) which only correctly categorized 22.15%.

This new tool provides a more accurate assessment of exercise capability compared to ADS, making it a valuable option for practitioners in both clinical and nonclinical settings, especially in low-resource environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calculated metabolic equivalents: a tool for exercise prescription among African American women. Gaydos, LM., Pullen, PR., Hogue, CJ., et al.[2022]

In a study involving 99 older adults with varying levels of mobility, the StepWatch and Fitbit One were found to be the most accurate step detectors, with underestimations of only 1.7% to 4.4% for nonimpaired and impaired individuals, indicating their reliability for tracking physical activity in this population.

In contrast, the Fitbit Flex showed significant underestimation of steps (up to 26.9% for nonimpaired adults), suggesting it may not be suitable for accurate step counting in older adults, especially those with mobility impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Consumer-Based Hip and Wrist Activity Monitors in Older Adults With Varied Ambulatory Abilities. Floegel, TA., Florez-Pregonero, A., Hekler, EB., et al.[2019]

The adaptive step goal and reward intervention delivered through the Just Walk smartphone app led to a significant increase in daily steps by an average of 2650 steps among 20 overweight participants over a 14-week period.

Participants reported high satisfaction with the app and appreciated the variability in daily goals, suggesting that this tailored approach could effectively promote increased physical activity in sedentary adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive step goals and rewards: a longitudinal growth model of daily steps for a smartphone-based walking intervention. Korinek, EV., Phatak, SS., Martin, CA., et al.[2022]

In a study of 339 elderly individuals aged 60-89 in Japan, daily step count was found to correlate with walking ability, including walking speed and balance, indicating that tracking steps can be a useful health promotion tool for older adults.

The research revealed that 41.7% of men and 28.8% of women had low-level walking, primarily due to factors like intermittent claudication and fear of falling, suggesting that encouraging daily walking could improve overall health and mobility in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Utility of the number of steps walked daily as a health promotion parameter in community-dwelling elderly persons]. Shibutani, T.[2019]

The article reviews the use of pedometers to measure physical activity, suggesting that a daily goal of 10,000 steps is a reasonable target for healthy adults, based on emerging evidence of health benefits associated with this level of activity.

However, the 10,000 steps/day goal may not be suitable for everyone, particularly older adults and those with chronic diseases, and alternative indices are proposed to better classify activity levels, such as <5000 steps/day for sedentary lifestyles and >12,500 steps/day for highly active individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How many steps/day are enough? Preliminary pedometer indices for public health. Tudor-Locke, C., Bassett, DR.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of Adherence to a Step Count Intervention Following Total Knee Replacement: An Exploratory Cohort Study. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Correlation between hip osteoarthritis and the level of physical activity as measured by wearable technology and patient-reported questionnaires. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Day-to-day variability of knee pain and the relationship with physical activity in people with knee osteoarthritis: an observational, feasibility study using consumer smartwatches. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Calculated metabolic equivalents: a tool for exercise prescription among African American women. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Validation of Consumer-Based Hip and Wrist Activity Monitors in Older Adults With Varied Ambulatory Abilities. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Adaptive step goals and rewards: a longitudinal growth model of daily steps for a smartphone-based walking intervention. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

[Utility of the number of steps walked daily as a health promotion parameter in community-dwelling elderly persons]. [2019]

10. New Zealand pubmed.ncbi.nlm.nih.gov

How many steps/day are enough? Preliminary pedometer indices for public health. [2022]