Arthritis Ease Study

NCT ID: NCT05721352

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2024-09-11

Brief Summary

The goal of this clinical trial is to test using a pain and anxiety reduction phone application in older adults with knee osteoarthritis and chronic pain. The main questions it seeks to answer are:

1. How acceptable is using a phone app in older adults with knee osteoarthritis and chronic pain to lower pain, pain stress and reduce fear of movement?

2. What are the effects of combining biofeedback with a virtual reality nature scene and paced breath training to increase heart rate variability on pain and anxiety among older adults with knee osteoarthritis?

3. What is the role of self-regulation and body awareness in predicting or strengthening the effect of combining virtual reality, heart rate variability biofeedback in older adults with knee osteoarthritis?.

Participants will be asked to:

1. use a phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks.

2. receive relaxation reminders weeks 9 through 12 to see if use continues past the intervention phase.

3. complete surveys describing pain, physical activity, fear of movement, body awareness and self-regulation, pain stress pre/post the app use.

4. complete a survey and interview after 8 weeks of phone app use to describe the experience of its use.

Detailed Description

Purpose: This single-group pre-post intervention design, study will explore the feasibility of using a multicomponent phone-based app for 8 weeks to reduce pain, pain stress effects, decreased heart rate variability and fear of movement in 24 older adults with knee osteoarthritis and to examine sustained use and or effects at 4 weeks after intervention period.

Aim 1 Evaluate the feasibility (adherence and satisfaction) of a multicomponent phone app combining virtual reality and heart rate variability biofeedback for use in older adults with knee osteoarthritis and chronic pain and gain descriptive evaluations of the experience in exit interviews.

Adherence: The adherence benchmark will be 80% of participants will participate at least 5 days per week during the initial 8-week intervention period. Adherence will be examined (not benchmarked) during the 4-week follow-up period.

Satisfaction: Exit interviews will demonstrate that 80% of participants practicing with the phone app rate the experience as satisfying or highly satisfying.

Aim 2 Evaluate the preliminary effects of multicomponent phone app use (5 days a week for 8 weeks) in older adults with knee osteoarthritis, in relation to pain, pain stress effects, and fear of movement (kinesiophobia), and examine sustained use patterns and effects with only reminders from the app during the 4-week follow-up period.

Aim 3: Examine the role of body awareness and self-regulation to moderate (predict) or mediate (strengthen) the effect of a virtual reality nature scene and heart rate variability biofeedback phone application in older adults with knee osteoarthritis.

Conditions

Knee Osteoarthritis; Chronic Pain; Kinesiophobia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single Arm Study

• All participants will receive access to the phone application with a virtual reality headset and heart rate variability Bluetooth ear sensor.
• Participants will be instructed to download a free phone app Elite Heart Rate Variability, login using study provided de-identified research email address, pair the Bluetooth ear sensor and record a five-minute resting heart rate variability reading at baseline and each time point of the study prior to beginning intervention.
• Participants will be asked to use the intervention phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks.
• For the first 8 weeks, participants will receive brief, daily texts encouraging participation in the smart phone application.
• During weeks 9 through 12, will receive relaxation reminders daily via text to determine if use is sustained past the intervention phase

Group Type: EXPERIMENTAL

Virtual Reality Nature scene plus heart rate variability biofeedback phone application

Intervention Type: BEHAVIORAL

phone app for slow- paced breath training with biofeedback in a virtual reality nature scene

Interventions

Virtual Reality Nature scene plus heart rate variability biofeedback phone application

phone app for slow- paced breath training with biofeedback in a virtual reality nature scene

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English speaking adults
• Diagnosed osteoarthritis of the knee(s)
• smart phone access
• Pain scale rating of 4-10 on the numerical pain rating scale (0- 10) \
• Pain duration of 3 months or greater
• Score of 15 or greater on the Tampa Scale of Kinesiophobia (fear of movement) scale

Eligibility includes:

• Willingness to engage in the study for 8 weeks
• Being available for 1-3 phone calls for data collection at pre- and post-8-week intervention and at 4 weeks post-intervention conclusion

Exclusion Criteria

• Self-report of: acute illness,
• Cancer
• HIV
• Systemic inflammatory disease (rheumatoid arthritis, lupus)
• History of neurologic disease, seizure disorder,
• Current or history of mental illness illness with hallucinations
• Motion sickness or vestibular disorders
• Acute or chronic respiratory disease
• Dysrhythmic heart disease
• Beta or calcium channel blocker medication use
• Monovision \\
• Current use of Heart rate variability training activities will also be excluded

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Linda Larkey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Larkey, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

00013939

Identifier Type: -

Identifier Source: org_study_id