Fatigability in Long COVID-19

NCT05699538 | Completed

• 1 other identifier: F4371-P
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to advance the understanding of underlying mechanisms impacting performance fatigability and perceived fatigability in Veterans with post-COVID-19 fatigue and explore the safety and feasibility of a home-based "minimal-dose" resistance exercise program in this population. The central hypothesis is that declines in force capacity, skeletal muscle oxygen extraction, and affective responses to physical activity offer potential mechanisms through which fatigability is increased in Veterans with post-COVID-19 fatigue. Moreover, home-based resistance exercise delivered remotely may provide a safe and feasibility treatment option for targeting neuromuscular and neurobehavioral factors influencing fatigability severity in this population.

Conditions

Long COVID

Keywords

resistance exercise; fatigue; COVID-19; near infrared spectroscopy; strength

Outcome Measures

Primary Outcomes (1)

• Performance fatigability

  Performance fatigability will be assessed as change in maximal voluntary isometric contraction (MVIC) torque of the dominant leg. Change in MVIC torque from the initial MVIC contraction to the last MVIC contraction will be used to determine the Performance Fatigability index.

  baseline and week 8

Secondary Outcomes (15)

• Rating of Perceived Fatigue (RPF)

  baseline and week 8

• Isometric and Isokinetic Knee Extensor Torque

  baseline and week 8

• Skeletal muscle oxygen extraction

  baseline and week 8

• Feeling Scale

  baseline and week 8

• Fatigue Severity Scale (FSS)

  baseline and week 8

Study Arms (2)

Minimal-Dose Home-Based Resistance Exercise

EXPERIMENTAL

8-week home-based resistance exercise performed one day per week.

Behavioral: Minimal-Dose Home-Based Resistance Exercise

Standard of Care

NO INTERVENTION

Subjects will be asked to follow standard of care recommendations as prescribed by the physician.

Interventions

Minimal-Dose Home-Based Resistance Exercise BEHAVIORAL

8-week home-based resistance exercise performed one day per week.

Minimal-Dose Home-Based Resistance Exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ambulatory patients (with or without a gait aid)
• years of age or older
• with a confirmed diagnosis of COVID-19 by polymerase chain reaction (PCR) test, antibody test or clinical diagnosis
• the symptom of fatigue reported greater than 12-weeks post-infection (reporting fatigue: yes/no)
• receiving care at the DC VAMC
• the ability to speak and read English, and orientation to person, place, and time
• the comparison group will include ambulatory patients (with or without a gait aid)
• years of age or older
• with a confirmed diagnosis of COVID-19 by PCR test, antibody test or clinical diagnosis
• without the symptom of fatigue reported greater than 12-weeks post-infection
• receiving care at the DC VAMC
• the ability to speak and read English, and orientation to person, place, and time

You may not qualify if:

• \<50 years of age without a confirmed diagnosis of COVID-19 by PCR test
• antibody test or clinical diagnosis or with a confirmed diagnosis of COVID-19 of \<12-weeks
• non-ambulatory individuals
• Veterans who do not use the DC VAMC as their main site for care
• body mass index 40 kg/m2
• diagnosis of psychiatric disorder(s)
• any medically uncontrolled cardiovascular
• musculoskeletal disease, or other conditions that, in the opinion of the principal investigator, could make participation in the study unsafe
• any orthopedic or joint pain which would prevent the participant from safely engaging in the study protocol
• additionally, individuals with plans to relocate from the DC metro area within one year will not be eligible for the intervention portion of the study

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422-0001, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue; COVID-19

Condition Hierarchy (Ancestors)

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; Signs and Symptoms

Study Officials

• Jared M. Gollie, PhD

  Washington DC VA Medical Center, Washington, DC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled pilot study

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: January 26, 2023
• Study Start: July 31, 2023
• Primary Completion: July 4, 2025
• Study Completion: September 30, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)