Clinical trial NCT03987932: NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Official title: NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sedentary Lifestyle
Knee Osteoarthritis
Knee Injuries
Knee Pain Chronic
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.

Detailed description: Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function. Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors. To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time. Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention. Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group. Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.

Eligibility criteria: Inclusion Criteria:

* Be at least 40 years of age
* Own an Android or Apple smartphone
* Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for \>50% of their waking day
* Be willing to download the study application and be compatible on their smartphone
* Spend at least 7 hours/day sitting
* Have at least 4 days of valid accelerometer data at baseline
* Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years
* Read, speak, and understand English

Exclusion Criteria:

* Have any contraindications to activity
* Have a mobility limiting comorbidity
* Have a scheduled surgery within the next 6 months

Primary outcomes:
measure: Change in Sedentary Behavior at 1 Month
timeFrame: Baseline to 1 month
measure: Change in Sedentary Behavior at 3 Months
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in Timed Up & Go at 1 Month
timeFrame: Baseline to 1 month
measure: Change in Chair Stands at 1 Month
timeFrame: Baseline to 1 month
measure: Change in 6 Minute Walk at 1 Month
timeFrame: Baseline to 1 month
measure: Change in Timed Up & Go at 3 Months
timeFrame: Baseline to 3 months
measure: Change in Chair Stands at 3 Months
timeFrame: Baseline to 3 months
measure: Change in 6 Minute Walk at 3 Months
timeFrame: Baseline to 3 months
Other outcomes:
measure: Maintenance of Changes in Sedentary Behavior at 6 Months
timeFrame: Baseline to 6 months
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: