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Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

Primary Purpose

Covid19, Physical Disability

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
heat therapy
exercise training
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Covid19 focused on measuring physical rehabilitation, cardio-vascular function, metabolism, heat therapy

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Women must not be taking hormone therapy
  • Must have been hospitalized for, at least, 5 days for a COVID-19 related infection
  • Must have been discharged from the hospital for, at least, 14 days

Exclusion Criteria:

  • Orthopedic limitations that would prohibit from performing plantar-flexion or knee-extension exercise
  • Contraindication to MRI (pacemaker, metal implants, or certain types of heart valves), or be at medical risk from undergoing an MRI examination
  • Enrolled in a rehabilitation program
  • BMI <40 kg/m2 and weigh <400lbs
  • prior history of pulmonary embolism or deep vein thrombosis

Sites / Locations

  • Institute of Applied Life SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Exercise training

heat therapy

Arm Description

Course of recovery with standard of care.

low resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks

heat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks

Outcomes

Primary Outcome Measures

Gait speed
6-min walking distance

Secondary Outcome Measures

Motor function
Short Physical Performance Battery score
Glucose control
insulin and glucose levels during oral glucose tolerance test
Skeletal muscle mitochondrial function
Change in phosphocreatine recovery kinetics measured by 31-PMRS
Vascular function
Change in reactive hyperemia

Full Information

First Posted
October 23, 2020
Last Updated
April 27, 2021
Sponsor
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT04673318
Brief Title
Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
Official Title
Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Older adults and people with underlying medical conditions are at higher risk for developing serious complications related to SARS-CoV-2 resulting in prolonged sequelae. The goal of this proposal is to compare the benefits of home-based lower limb heat therapy to exercise training on cardio-metabolic function and mobility in older adults during their convalescence from hospitalization due to SARS-CoV-2.
Detailed Description
The novel coronavirus (severe acute respiratory syndrome [SARS]-CoV-2), first identified in December 2019 in Wuhan, China, has since spread worldwide. Older adults and people with underlying medical conditions are at higher risk for developing serious complications and death related to SARS-CoV-2. However, another challenge is arising in regards to the long-term prognosis of COVID-19 survivors. Although limited, the available data on the medium-term outcomes of patients who survived COVID-19 all indicate prolonged symptom duration and disability in a large proportion of adults hospitalized with severe symptoms. In addition, these patients, a majority of whom were older adults or patients with pre-existing health conditions, spent ~10-15 days bedridden and under intensive treatment, which can have lasting consequences on metabolism and cardiovascular functions, mobility, and eventually lead to long-term disabilities. Upon discharge from the hospital, the main option for physical rehabilitation involves exercise training. Although, exercise training can be effective to restore physical function, it is oftentimes associated with low adherence. Considering the severe deconditioning accompanying hospitalization related to COVID-19, there is a critical need for the development of a rehabilitation strategy that is home-based and practical to individuals with diminished physical function. Accordingly, the goal of this project is to compare the benefits of home-based lower limb chronic heat therapy to exercise training on skeletal muscle metabolism, vascular function and functional capacity in older adults during their convalescence from hospitalization due to SARS-CoV-2. Late middle-age and older adults that have been discharged from a COVID-19 hospitalization will be randomly allocated to an exercise intervention group (EX, low resistance ~40 min, 3 times a week at home), a heat-treated group (HT, leg heated garments with skin temperature reaching ~40˚C, 40-55 min, 5 times a week at home), or a control group (CT) for 8 weeks. Specific Aim 1 will test the hypothesis that local heat therapy in previously hospitalized COVID-19 patients can (i) enhance functional capacity, resulting in improvements in mobility and quality of life compared to a non-treated control group, and (ii) that these changes will be similar in magnitude to an exercise intervention. Specific Aim 2 will test the hypothesis that local heat therapy in the same patients can (i) enhance insulin sensitivity as a consequence of improvements in mitochondrial and vascular function compared to a non-treated control group, and (ii) that these changes will be similar in magnitude to an exercise intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Physical Disability
Keywords
physical rehabilitation, cardio-vascular function, metabolism, heat therapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Course of recovery with standard of care.
Arm Title
Exercise training
Arm Type
Active Comparator
Arm Description
low resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks
Arm Title
heat therapy
Arm Type
Experimental
Arm Description
heat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
heat therapy
Other Intervention Name(s)
exercise training
Intervention Description
leg heated garments with circulating water to conduct heat therapy at home
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.
Primary Outcome Measure Information:
Title
Gait speed
Description
6-min walking distance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Motor function
Description
Short Physical Performance Battery score
Time Frame
8 weeks
Title
Glucose control
Description
insulin and glucose levels during oral glucose tolerance test
Time Frame
8 weeks
Title
Skeletal muscle mitochondrial function
Description
Change in phosphocreatine recovery kinetics measured by 31-PMRS
Time Frame
8 weeks
Title
Vascular function
Description
Change in reactive hyperemia
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women must not be taking hormone therapy Must have been hospitalized for, at least, 5 days for a COVID-19 related infection Must have been discharged from the hospital for, at least, 14 days Exclusion Criteria: Orthopedic limitations that would prohibit from performing plantar-flexion or knee-extension exercise Contraindication to MRI (pacemaker, metal implants, or certain types of heart valves), or be at medical risk from undergoing an MRI examination Enrolled in a rehabilitation program BMI <40 kg/m2 and weigh <400lbs prior history of pulmonary embolism or deep vein thrombosis
Facility Information:
Facility Name
Institute of Applied Life Sciences
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenael Layec, PhD
Phone
413-545-1451
Email
glayec@umass.edu
First Name & Middle Initial & Last Name & Degree
Mary Emma Searles
Email
msearles@umass.edu

12. IPD Sharing Statement

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Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

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