RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in frequency of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
研究概览
简要总结
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).
The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.
详细描述
Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence.
The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and
排除标准
- •which applies to this appendix
- •Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria:
- •Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
- •Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND Answer of YES to either item 7 or 8 on Screening mDSQ-PEM, and response of >14 h in item
- •or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of >14h in item
- •Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria:
- •Inability to attend in-person screening visit or participate in weekly visits (in-person [≥ 1] and remote)
- •Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A
研究组 & 干预措施
Structured Pacing (PEM)
Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications.
干预措施: Structured Pacing (Behavioral)
Usual Care
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in frequency of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
时间窗: Baseline, week 12 (End Of Intervention (EOI)), month 6 (End of Study (EOS))
Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.
Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
时间窗: Baseline, week 12 (EOI), month 6 (EOS)
Change in severity of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
时间窗: Baseline, week 12 (EOI), month 6 (EOS)
Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
Change in frequency of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
时间窗: Baseline, week 12 (End Of Intervention (EOI)
Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.
Change in severity of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
时间窗: Baseline, week 12 (EOI)
Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
时间窗: Baseline, week 12 (EOI)
次要结局
- Change in PASC symptoms, as measured by the PROMIS-Cog Questionnaire(Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))
- Change in quality of life, as measured by the PROMIS-29+2(Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))
- Change in physical activity, as measured by the PROMIS SF-Physical Function (PROMIS-PF)(Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))
- Change in PASC symptoms, as measured by the PASC Symptom Questionnaire(Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))
- Change in physical activity, as measured by Actigraphy(Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))
- Change in quality of life, as measured by the EQ-5D 5L(Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))
- Change in orthostatic hypotension, as measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)(Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS))