Optimizing a Remote-based Physical Activity Intervention for Adults With Total Knee Replacement

Обзор

The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines \[≥150 min/week of MVPA\]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.

Подробное описание

All participants will receive a 6-month, fully automated online behavioral exercise program (Energize! Exercise Program). This program is designed to increase moderate-intensity physical activity among individuals who engage in little to no physical activity at baseline. Over the course of the program, participants are given a physical activity goal which starts at 75 minutes per week and gradually progresses to 200 minutes per week. Participants are instructed to view a 10-15-minute video lesson weekly, during months 1-3, and monthly during months 4-6. These lessons teach behavioral principles for increasing exercise and maintaining physical activity long-term. Participants are also asked to complete an 'Apply Your Knowledge' activity after watching each video lesson. These activities are designed to help the participant engage more with the lesson content, with a particular emphasis on applying the content to their lives. Within this program, participants are also asked to plan and report their exercise each week, and automated feedback is provided based upon their weekly physical activity reports.

In addition to receiving the Energize! Exercise Program, participants will be randomly assigned to receive 0-4 supplemental intervention components (phone coaching, progress reports to providers, 'Hear From Others' videos, and individualized feedback) which are each described in more detail below.

Вмешательства

• Поведенческое Phone Coaching
  Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes.
• Поведенческое Progress reports to providers
  Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
• Поведенческое 'Hear from Others' Videos
  Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity.
• Поведенческое Individualized Feedback
  Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6.
• Поведенческое Online exercise program
  MOST Energized! Online Exercise Program

Первичные конечные точки

• Physical activity (min/week) [Срок оценки: Baseline to 6 months]
• Percentage meeting physical activity guidelines [Срок оценки: 6 months]
• Physical activity (min/week) [Срок оценки: Baseline to 12 months]
• Percentage meeting physical activity guidelines [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Pain intensity [Срок оценки: Baseline to 6 months]
• Physical Function [Срок оценки: Baseline to 6 months]
• Pain intensity [Срок оценки: Baseline to 12 months]
• Physical Function [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• had a knee replacement (including primary, staged or independent bilateral, or revision) at least 12 months ago
• have a computer, tablet, or smartphone with active internet access
• self-report engaging in less than 60 minutes/week of moderate-intensity physical activity
• be English-speaking and able to read consent and study materials written in English
• be willing to complete the 4 remote assessments, including physical activity monitoring
• be willing to be randomized to receive 0-4 supplemental intervention components.

Критерии исключения

• any contraindications to physical activity (e.g., chest pain)
• have a scheduled surgery within the next 12 months (e.g., hip or knee replacement)
• have a mobility limiting comorbidity unrelated to knee replacement
• live outside of the continental U.S
• do not currently have a physician or orthopedic surgeon whom they see regularly
• are currently participating in physical therapy (for knee)
• are participating in a structured weight loss or physical activity program
• unable to provide proof of knee replacement surgery
• have a BMI >40kg/m2
• score >30 on PROMIS cognitive function

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of South Carolina — Columbia

Публикации

• Kennerley CL, Coffman DL, Kim Y, Nelson J, Jackson JB 3rd, Jamieson S, Horn K, Stansbury ML, Wilson-Barthes M, Unick JL, Pellegrini CA. Identifying the most effective components of a physical activity intervention for adults with knee replacement: the MOST Energized! study protocol. BMC Musculoskelet Disord. 2026 Mar 18;27(1):356. doi: 10.1186/s12891-026-09734-9. PMID 41845290

Идентификаторы

NCT: NCT06768762 · Pro00136251 · R01AG088083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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