Heat thErapy And mobiLity in COVID-19 Survivors

NCT06928116 | Recruiting DMC

• 2 other identifiers: 0550-24-FBR01AG089307
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities. Although exercise intervention is a common strategy to restore functional capacity, it may not be feasible or enticing to many people with PASC. This clinical trial seeks to establish the tolerability and efficacy of at home lower-body heat therapy for improving functional capacity along with metabolic and vascular health in late-middle aged and older adults with PASC, also known as "long COVID".

Conditions

Long COVID

Keywords

Heat Therapy; mobility limitations; Post-acute sequelae of SARS-CoV-2 infection (PASC)

Outcome Measures

Primary Outcomes (3)

• 6 min walking distance

  Distance covered during 6 min of walking

  8 weeks

• Short Physical Performance Battery Test

  Test of physical functional capacity

  8 weeks

• Arterial stiffness

  Pulse Wave velocity

  8 weeks

Study Arms (3)

Heat Therapy

EXPERIMENTAL

At home heat therapy 5 times (40-55 min) per week for 8 weeks.

Behavioral: Heat therapy

Control Therapy

SHAM COMPARATOR

Sham at home thermoneutral therapy 5 times (40-55 min) per week for 8 weeks.

Behavioral: Sham Control

Walking Intervention Using Wearable Technology

ACTIVE COMPARATOR

+1,500-3000 steps per day 3-5 days a week for 8 weeks.

Behavioral: Walking

Interventions

Heat therapy BEHAVIORAL

At home lower body heat therapy

Heat Therapy

Sham Control BEHAVIORAL

Sham Thermoneutral

Control Therapy

Walking BEHAVIORAL

Walking intervention

Walking Intervention Using Wearable Technology

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 50 and 90 years
• Free from orthopedic limitations that would prohibit performing leg exercise
• BMI \< 40 kg/m2 and weigh \< 400lbs
• Previously contracted Covid-19 and have persistent symptoms such as a fatigue or decline in physical function, for at least 2 months following SARS-CoV-2 infection

You may not qualify if:

• Unable to give written informed consent
• Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months
• Women who are taking hormone therapy
• Claustrophobia
• Orthopedic limitations that would prohibit them from walking
• Currently enrolled in an exercise-based or respiratory muscle rehabilitation program.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Nebraska Omaha

Omaha, Nebraska, 68182, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Hyperthermia; Mobility Limitation

Interventions

Diathermy; Walking

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; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Gwenael Layec, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwenael Layec, PhD

CONTACT

402-554-3779; unovrl@unomaha.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 15, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: October 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The research community will have access to data at the end of the grant award or when a publication has been submitted, whichever comes first.
• Access Criteria: Data will be deposited on open access platform and we will use standard rights waivers established by Open Data Commons (ODC).

Locations

US (1)