Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172803
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2023-12-14
Brief Title:
Restoring Energy With Sub-symptom Threshold Optimized Rehabilitation Exercise for Long COVID
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
RESToRE Restoring Energy With Sub-symptom Threshold Optimized Rehabilitation Exercise for Long COVID
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESToRE
Brief Summary:
The overall goal of this study is to find out if rehabilitation exercise can help people who have long COVID Participants will be randomized by chance to receive either aerobic exercise or breathing exercise combined with stretches Participants will be guided and supported in completing a tailored 6-week home exercise program to be performed 5 - 6 days a week prescribed and supervised by rehabilitation therapists Participants will perform breathing exercises which will be supervised by an occupational therapist The focus of Aim 1 is to determine feasibility of implementing RESToRE in long COVID
Detailed Description:
Long COVID also known as post-acute coronavirus 2019 syndrome is characterized by debilitating multi-organ symptoms beyond 3 months from the onset of acute illness consistent with autonomic nervous system dysfunction Prevalence estimate of long COVID is 10 - 20 of survivors of COVID-19 representing about 10-20 million global long-term cases Multi-organ autonomic-related symptoms of long COVID such as exhausting fatigue and post-exertional malaise are remarkably like post-concussion syndrome and chronic fatigue syndrome Post-exertional malaise likely a cardinal symptom of long COVID is an exacerbation of some or all of an individuals symptoms after physical or cognitive exertion or orthostatic stress significantly impacting functional ability and quality of life This abnormal response to exertion is often described as flu-like and typically includes brain fog Common long hauler symptoms reported in our cohort of patients with long COVID n30 were fatigue 70 symptoms of dysautonomia 80 primarily orthostasis brain fog 100 and new or worse mood symptoms 90 especially anxiety Experience from Severe Acute Respiratory Syndrome SARS-CoV-1 notably showed that survivors suffered chronic fatigue and mental illnesses 4 years after acute viral illness Rehabilitation studies in coronavirus disease Covid-19 have targeted sub-acute lung sequelae of Covid-19 rather than post-acute sequalae of long COVID This study addresses the World Health Organizations urgent call for rehabilitation research for long COVID
The investigators identified blunted rise in heart rate HR called chronotropic intolerance during maximal cardiopulmonary exercise testing CPET in 19 adults with long COVID Chronotropic intolerance is defined as inability to meet 80 of age-derived heart rate HR peak Group HR peak mean SD was 69 77 predicted This blunted rise in HR is associated with post-exertional malaise similar to the pattern of symptoms in post-concussion syndrome and chronic fatigue syndrome which share underlying autonomic nervous system ANS dysfunction and impaired cerebral blood flow regulation The investigators identified a need for more comprehensive and precise measurement of post-exertional malaise in long COVID In a randomized controlled trial RCT the investigators also tested a sub-symptom threshold aerobic exercise program focused on treating persisting symptoms of post-concussion syndrome The investigators found this aerobic exercise program reduced persistent symptoms of exercise intolerance fatigue and dysautonomia more quickly in subjects compared with a control group of stretching exercises n103
Informed by research in post-concussion syndrome the investigators are proposing a two-arm randomized controlled trial RCT to study the feasibility of an exercise program called Restoring Energy with Sub-symptom Threshold Aerobic Rehabilitation Exercise RESToRE The central hypothesis is that restoration of autonomic control through RESToRE will resolve persisting symptoms of long COVID faster compared with placebo-like stretching and breathing exercise without rise in HR RESToRE is an interdisciplinary hybrid 8-week intervention consisting of three core components 1 home-based aerobic exercise of 20 minutes most days with HR monitoring at 70-80 of the HR threshold at which symptoms increase 2 phone-based motivational exercise coaching 20 minutes weekly and 3 supervised exercise with an exercise physiologist twice-monthly in the clinic Key to RESToREs feasibility is its telehealth component including Apple watch and app for HR fidelity monitoring PhysiTracks exercise library app and LifeData dashboard for real-time post-exertional malaise and remote exercise monitoring Our long-term goal is to establish an efficacious exercise program to speed recovery from long COVID
The investigators identified blunted rise in heart rate HR called chronotropic intolerance during maximal cardiopulmonary exercise testing CPET in 19 adults with long COVID Chronotropic intolerance is defined as inability to meet 80 of age-derived heart rate HR peak Group HR peak mean SD was 69 77 predicted This blunted rise in HR is associated with post-exertional malaise similar to the pattern of symptoms in post-concussion syndrome and chronic fatigue syndrome which share underlying autonomic nervous system ANS dysfunction and impaired cerebral blood flow regulation The investigators identified a need for more comprehensive and precise measurement of post-exertional malaise in long COVID In a randomized controlled trial RCT the investigators also tested a sub-symptom threshold aerobic exercise program focused on treating persisting symptoms of post-concussion syndrome The investigators found this aerobic exercise program reduced persistent symptoms of exercise intolerance fatigue and dysautonomia more quickly in subjects compared with a control group of stretching exercises n103
Informed by research in post-concussion syndrome the investigators are proposing a two-arm randomized controlled trial RCT to study the feasibility of an exercise program called Restoring Energy with Sub-symptom Threshold Aerobic Rehabilitation Exercise RESToRE The central hypothesis is that restoration of autonomic control through RESToRE will resolve persisting symptoms of long COVID faster compared with placebo-like stretching and breathing exercise without rise in HR RESToRE is an interdisciplinary hybrid 8-week intervention consisting of three core components 1 home-based aerobic exercise of 20 minutes most days with HR monitoring at 70-80 of the HR threshold at which symptoms increase 2 phone-based motivational exercise coaching 20 minutes weekly and 3 supervised exercise with an exercise physiologist twice-monthly in the clinic Key to RESToREs feasibility is its telehealth component including Apple watch and app for HR fidelity monitoring PhysiTracks exercise library app and LifeData dashboard for real-time post-exertional malaise and remote exercise monitoring Our long-term goal is to establish an efficacious exercise program to speed recovery from long COVID
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None