NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries

Knee Osteoarthritis Clinical Trial

Official title:

NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03987932
• Other study ID #: Pro00085868
• Status: Terminated
• Phase: N/A
• Start date: June 22, 2019
• Est. completion date: September 9, 2020

Study information

• Verified date: June 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis, Knee
• Sedentary Lifestyle
• Wounds and Injuries

Intervention

Behavioral:
• NEAT!2
Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
• NEAT!2+Calls
Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
• Delayed NEAT!2
Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maintenance of Changes in Sedentary Behavior at 6 Months	Daily sedentary behavior objectively measured by activpal	Baseline to 6 months
Primary	Change in Sedentary Behavior at 1 Month	Daily sedentary behavior objectively measured by activpal	Baseline to 1 month
Primary	Change in Sedentary Behavior at 3 Months	Daily sedentary behavior objectively measured by activpal	Baseline to 3 months
Secondary	Change in Timed Up & Go at 1 Month	Physical function assessed by Timed Up & Go (seconds)	Baseline to 1 month
Secondary	Change in Chair Stands at 1 Month	Physical function assessed by Chair Stand Test (# stands in 30 seconds)	Baseline to 1 month
Secondary	Change in 6 Minute Walk at 1 Month	Physical function assessed by 6 minute walk (total feet)	Baseline to 1 month
Secondary	Change in Timed Up & Go at 3 Months	Physical function assessed by Timed Up & Go (seconds)	Baseline to 3 months
Secondary	Change in Chair Stands at 3 Months	Physical function assessed by Chair Stand Test (# stands in 30 seconds)	Baseline to 3 months
Secondary	Change in 6 Minute Walk at 3 Months	Physical function assessed by 6 minute walk (total feet)	Baseline to 3 months