NCT05534997

Brief Summary

The aim of this study is to investigate the effect of intensive combined rehabilitation therapy in form of Graded Exercise Therapy (GET) , Cognitive Behavioral Therapy (CBT) to treat patients with post COVID19 chronic fatigue syndrome .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

August 26, 2022

Last Update Submit

September 8, 2022

Conditions

Post-COVID-19 Syndrome

Keywords

chronic fatiguegraded exercisecognitive behavioral therapy

Outcome Measures

Primary Outcomes (4)

  • The fatigue severity level

    The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)

    12 weeks

  • aerobic capacity and endurance

    Aerobic capacity and endurance will be measured via The 6 Minute Walk Test. The test will be performed at Modern University for the technology and information rehabilitation center corridor.

    12 weeks

  • Maximal hand grip strength and fatigue resistance

    Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer

    12 weeks

  • the Fall risk

    Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).

    12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

will receive the post covid protocol conventional treatment in form of medication and 24 sessions of combined rehabilitation exercise program in the form of Graded exercise therapy (GET) and cognitive behavioral therapy (CBT). Patients will attend two sessions per week for 12 weeks. Sessions will be taken at Modern university for technology and information physical therapy rehabilitation center . A home exercise program will be prescribed on at least five days a week. Patients will be contacted by phone daily for the 12 weeks treatment sessions, for following up the home exercise program.

Other: intensive combined rehabilitation therapy

Group B

NO INTERVENTION

will receive the post covid protocol conventional treatment in form of medication and specialist medical care provided by doctors with specialist experience in CFS. All patients will be given a leaflet explaining the illness and the nature of this treatment. Treatment will consist of an explanation of chronic fatigue syndrome, generic advice such as to avoid extremes of activity and rest, specific advice on self-help and symptomatic pharmacotherapy (especially for insomnia, pain and mood) .

Interventions

intensive combined rehabilitation therapyOTHER

graded exercise therapy and cognitive behavioral therapy

Group A

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • post covid patients (6 months recovery after last negative PCR diagnosis)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.

    PMID: 32784198BACKGROUND

  • Elboim-Gabyzon M, Buxbaum R, Klein R. The Effects of High-Intensity Interval Training (HIIT) on Fall Risk Factors in Healthy Older Adults: A Systematic Review. Int J Environ Res Public Health. 2021 Nov 11;18(22):11809. doi: 10.3390/ijerph182211809.

    PMID: 34831565BACKGROUND

  • Dennis A, Wamil M, Alberts J, Oben J, Cuthbertson DJ, Wootton D, Crooks M, Gabbay M, Brady M, Hishmeh L, Attree E, Heightman M, Banerjee R, Banerjee A; COVERSCAN study investigators. Multiorgan impairment in low-risk individuals with post-COVID-19 syndrome: a prospective, community-based study. BMJ Open. 2021 Mar 30;11(3):e048391. doi: 10.1136/bmjopen-2020-048391.

    PMID: 33785495BACKGROUND

  • Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997 Mar;154(3):408-14. doi: 10.1176/ajp.154.3.408.

    PMID: 9054791BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Samar Hosny, M.Sc. in Physical Therapy

CONTACT

+201207677743samarhosnipt@gmail.com

Abeer Yamany, Doctoral

CONTACT

+201006899872abeeryamany@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pre and post test parallel groups randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 10, 2022

Study Start

October 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

September 10, 2022

Record last verified: 2022-09