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Trial - NCT05534997


Column Value
Trial registration number NCT05534997
Full text link
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Samar Hosny, M.Sc. in Physical Therapy

Contact
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

samarhosnipt@gmail.com

Registration date
Last imported at : Sept. 26, 2022, 5 a.m.
Source : ClinicalTrials.gov

2022-09-10

Recruitment status
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: 60 post covid patients (6 months recovery after last negative pcr diagnosis) patients will be selected using the oxford diagnostic criteria for cfs which required disabling fatigue to be the primary problem, in the absence of an exclusionary medical or psychiatric diagnosis. patients will fulfil the following criteria for cfs : fatigue as a principal symptom. fatigue definite onset that is not life long. fatigue should have been present for a minimum of 6 months during which it was present for more than 50% of the time. other symptoms may be present, particularly myalgia, mood and sleep disturbance. both sexs will be included body mass index range from (18.5 to 24.9 kg/m2) patients' age range will be 18 to 34 years old . presence of significant fatigue since covid-19. able to understand and willing to sign a written informed consent document. willing and able to complete study procedures.

Exclusion criteria
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

on medications that would influence exercise performance such as beta blockers or antiretroviral therapy enrolled in another interventional clinical research trial pregnancy significant hepatic or renal dysfunction history or cardiac condition as determined by national institutes of health (nih) cardiology to be unsafe for exercise participation (e.g. ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non-idiopathic cardiomyopathy) patients with a current diagnosis of schizophrenia, manic depressive illness, substance abuse, eating disorder or proven organic brain disease.

Number of arms
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Cairo University

Inclusion age min
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

34

Countries
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

aerobic capacity and endurance;Maximal hand grip strength and fatigue resistance;the Fall risk;The fatigue severity level

Notes
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Sept. 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2603, "treatment_name": "Cognitive behavioral therapy+graded exercise therapy", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]