Restoring Energy With Sub-symptom Threshold Optimized Rehabilitation Exercise for Long COVID

NCT06172803 | Completed

• 1 other identifier: AAAU4504 (Aim 1)
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Long Covid19; Exercise Intolerance; Riboflavin-Responsive

Keywords

Riboflavin; Rehabiliation; Long COVID

Outcome Measures

Primary Outcomes (3)

• Number of participants who enrolled

  Feasibility of the RESToRE program will be determined by measuring the number of participants who enroll.

  10 weeks

• Number of participants who completed

  Feasibility of the RESToRE program will be determined by measuring the number of participants who complete (participated through the end of the study).

  10 weeks

• Number of participants who adhered to session attendance

  Feasibility of the RESToRE program will be determined by measuring the number of participants who achieve ≥80% exercise adherence and session attendance.

  10 weeks

Secondary Outcomes (8)

• PROMIS-29 scale score

  baseline and post intervention at 8 weeks

• Rand 36-Item Health Survey (SF-36) score

  Baseline and Post Intervention at 8 weeks

• VO2 % predicted from Cardiopulmonary Exercise Testing (CPET)

  Baseline and post intervention at 8 weeks

• Number of participants with orthostatic hypocapnia.

  baseline and post intervention at 8 weeks

• EuroQol: Education Quotient-5D Visual Analogue Scale score

  baseline and post intervention at 8 weeks

Study Arms (2)

RESToRE

EXPERIMENTAL

Participants will receive RESToRE, an interdisciplinary, hybrid 8- week intervention.

Behavioral: Restoring Energy with Sub-symptom Threshold Aerobic Rehabilitation Exercise

Light Stretching Exercise

ACTIVE COMPARATOR

The control group will receive 8-week, attention-matched, stretching and breathing exercises, supervised by a rehabilitation clinician.

Behavioral: Light Stretching/Breathing Exercises

Interventions

Restoring Energy with Sub-symptom Threshold Aerobic Rehabilitation Exercise BEHAVIORAL

8 week exercise program. 20 minutes of home aerobic exercise most days, phone- based motivational exercise coaching and supervised exercise with our team exercise physiologist.

Also known as: RESToRE

RESToRE

Light Stretching/Breathing Exercises BEHAVIORAL

The control group will receive 8-week, attention-matched, stretching and breathing exercises, supervised by a rehabilitation clinician (via 20-minute weekly video visits). Exercises performed 5 days a week will not increase HR significantly. Participants will record and track their HR with Apple watch and app; like RESToRE, fidelity of treatment will be objectively measured using HR data.

Light Stretching Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Age of 21 years or older
• Diagnosis of long COVID
• Score \>0 on energy, daily activities, sleep, chest tightness, or breathlessness on COPD Assessment Test or self-reported brain fog
• Able to use a smartphone.

You may not qualify if:

• \>70years old due to risk of sarcopenia
• Frailty defined as gait speed \<1 m/s on 4- Meter Gait Speed (4MGS) test due to falls risk
• Diagnosis of chronic cardiac or pulmonary disease, including atrial fibrillation, ME/CFS, post-concussion syndrome, chronic Lyme disease, lupus, or sarcopenia comorbidities (due to PEM and/or fatigue)
• Medical history of ICU stay for COVID-19 illness due to risk of post-ICU syndrome and increased rehabilitation needs
• Inability to ambulate independently and safely without a walking aide
• Diagnosis of dementia or neurodegenerative disease, multiple sclerosis, or rheumatoid arthritis with associated cognitive dysfunction or fatigue.

Sponsors & Collaborators

• Columbia University: lead
• New York University: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Restore polishing paste; Breathing Exercises

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Anna Norweg, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 15, 2023
• Study Start: October 1, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

US (1)