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Trial - NCT04958161


Column Value
Trial registration number NCT04958161
Full text link
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04958161

First author
Last imported at : Feb. 25, 2022, 7 p.m.
Source : ClinicalTrials.gov

Michael J Berry, PhD

Contact
Last imported at : Feb. 25, 2022, 7 p.m.
Source : ClinicalTrials.gov

berry@wfu.edu

Registration date
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

2021-07-12

Recruitment status
Last imported at : Feb. 25, 2022, 7 p.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - 55 years of age or older - able to read and speak english - proof of a positive nucleic acid amplification test for the determination of covid-19 - two months post positive nucleic acid amplification test for the determination of covid - self-report of covid-19 symptoms (symptoms include any of the following: reduced exercise capacity, fatigue, cough, shortness of breath, headache and/or joint pain) - able to understand and willing to sign a written informed consent document - willing and able to complete all study procedures including attending all exercise sessions

Exclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

- currently exercising more than 60 minutes per week at a moderate intensity or 30 minutes per week at a high intensity - current use of supplemental oxygen - active treatment for cancer - severe congestive heart failure, pulmonary disease, stroke, peripheral vascular disease, coronary artery disease and/or valvular heart disease - positive graded exercise test - major psychiatric disease - severe liver or hepatic disease - uncontrolled hypertension or diabetes - orthopedic impairment that prevents participation in an exercise program - blindness - bmi > 40kg/m2 - living more than 35 miles from exercise facility - plans to move within the next 6 months

Number of arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Wake Forest University Health Sciences

Inclusion age min
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

55

Inclusion age max
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Feb. 25, 2022, 7 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Performance Based Physical Function;Performance Based Physical Function;Self-reported Physical Function;Self-reported Physical Function

Notes
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 987, "treatment_name": "Physical exercises", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]