Physiotherapy as a Complimentary Treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors With CoViD-19: A Clinical-Controlled Study

NCT04471831 | Unknown DMC

• 1 other identifier: CMUL/HREC/06/20/742
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv with multiple comorbidities. Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic acid content in the test sample (NA) will be recorded from the virology test results. Their exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes' walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements will be taken at every three days intervals from admission to discharge from hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video platforms will be used for the interactions between the physiotherapists and the participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and Nervous System Disorders research group of the University of Lagos, Nigeria will be used for the E-exercises. The exercise package will be loaded into the phones of the participants at hospital admission. The Physiotherapists will lead in the exercises through video interaction will the participants watches the video programme. Their risks for respiratory complications (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval). Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence for inclusion of Physiotherapy in the acute management of individuals tested positive for CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage to reduce the odds of developing complications expedite discharge and reduce odd of death.

Conditions

Corona Virus Infection; Stroke

Keywords

COVID19; Stroke patient/survivors; Viral load; Quality of life; Exercise capacity; Exercise endurance

Outcome Measures

Primary Outcomes (5)

• Cycle Threshold (CT) values as recorded from the series of the qRT-PCR

  The CT value of a reaction is defined as the cycle number when the fluorescence of a PCR product can be detected above the background signal. The CT value is associated with the amount of PCR product in the reaction. The lower the CT value, the more PCR product that is present. It does not have unit of measurement

  From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

• Nucleic acid values as calculated from the Cycle Threshold recorded from the series of the qRT-PCR

  This is the inverse of the Cycle Threshold. It does not have unit of measurement.

  From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

• Quality of Life perception

  Perceived life experience by the participants in relation to the present situation. It does not have unit of measurement.

  From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

• Exercise capacity

  The maximum amount of physical exertion that a patient can sustain. It will be tested using the 3-metre walk test. This is the time taken to complete a 3-metre distance. The unit of measurement is in seconds

  From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

• Exercise endurance

  The maximum length a patient can sustain an exercise procedure, It will be tested using the 3-minutes' walk test This is the distance covered within a 3-minute walk. The unit of measurement is in metres

  From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

Study Arms (2)

Stroke survivors with COVID19

EXPERIMENTAL

The active intervention group

Other: Rehabilitation exercise protocol

Non-stroke individuals with COVID19

PLACEBO COMPARATOR

Matching for age, sex and co-morbid status with the stroke survivors

Other: Rehabilitation exercise protocol

Interventions

Rehabilitation exercise protocol OTHER

The exercise package will then be sent to them after securing video contact with the prospective participant. Only participants with smart phone that can receive the video package will be selected for this study. Physiotherapy-Patients' Engagements At every morning after their prescribed drugs might have been served in the ward, the physiotherapist will call the participant for the exercises. The patient will be connected to the physiotherapist who is in his clinic (not in the isolation ward with the patients) through a WhatsApp or zoom video call. The physiotherapist will control the rhythm and pace of the exercises through the video interactions.

Non-stroke individuals with COVID19; Stroke survivors with COVID19

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors with COVID19
• Non-stroke individuals with COVID19

You may not qualify if:

• Stroke survivors still in inpatient hospital care

Sponsors & Collaborators

• University of Lagos, Nigeria: lead

MeSH Terms

Conditions

Coronavirus Infections; Stroke; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caleb AO Gbiri, PhD

  University of Lagos, Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb AO Gbiri, PhD

CONTACT

+2347084567759; cgbiri@unilag.edu.ng

Jibrin S Usman, MSc

CONTACT

+2348069766797; jibrilphysio@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The identification and selection of participants will be done by none of investigators. Allocation into group will also be done by none of the investigators. Outcome assessment will be done by none of the investigators. Participants will not be privy to another group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer and Neurophysiotherapist

Model Details: This clinical controlled study will involve a minimum of 30 stroke survivors who is positive for coronavirus (CoViD-19) admitted into different isolation centres in Nigeria

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 15, 2020
• Study Start: July 13, 2020
• Primary Completion: June 21, 2021
• Study Completion: December 31, 2021
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For data merging and comparison
• Access Criteria: on demand