NCT05425264

Brief Summary

The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jun 2023Jan 2028

First Submitted

Initial submission to the registry

June 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

3.6 years

First QC Date

June 16, 2022

Last Update Submit

November 5, 2025

Conditions

Post SARS-CoV2 (COVID-19)

Keywords

ExerciseCOVID-19Cardiopulmonary

Outcome Measures

Primary Outcomes (1)

  • Change in VO2peak

    physical fitness, units are ml/kg/min

    Baseline and after 12 weeks tele-exercise

Secondary Outcomes (2)

  • Change in 2-minute step test

    Baseline and after 12 weeks tele-exercise

  • chair stands

    Baseline and after 12 weeks tele-exercise

Study Arms (1)

Tele-exercise

EXPERIMENTAL

Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Other: Tele-exercise

Interventions

Tele-exerciseOTHER

Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Tele-exercise

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • documented COVID-19 \> 90 days ago
  • diagnosis of 2 of following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease OR 1 condition and BMI \> 30 kg/m2

You may not qualify if:

  • myocardial infarction (within 3 months)
  • exertional or unstable angina (chest pain that limits activity)
  • severe congestive heart failure (EF \< 20% in last year or NYHA Classification III or IV)
  • uncontrolled hypertension (SBP \>180 \&/or DBP \> 110 mm Hg at screening)
  • screening EKG with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
  • poorly controlled diabetes mellitus (FBS\>200 mg/dl, RBS \> 299 mg/dl, or HbA1C \> 10)
  • treatment for cancer except skin cancer (within 3 months)
  • peripheral vascular disease with claudication
  • severe arthritis limiting ambulation
  • neurologic disease limiting ambulation (weakness requiring assist device; severe neuropathy)
  • end stage liver disease (decompensated liver disease)
  • End stage renal failure (dialysis)
  • severe pulmonary disease (home O2, admission for dyspnea or pneumonia within 1 month)
  • high fall risk (history of falls, bone fracture)
  • dementia (based on Evaluation to Consent)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

COVID-19Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Alice S. Ryan, PhD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice S Ryan, PhD

CONTACT

(410) 605-7851Alice.Ryan@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Exercise tele-rehabilitation
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 21, 2022

Study Start

June 29, 2023

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)