NCT06251011

Brief Summary

This study aims to evaluate the effects of Physiotherapy Via Video Calls on Cardiopulmonary Functions, Physical Function, Cognitive Function, Activity Daily Livings, and Quality of Life in Patients With COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

February 7, 2024

Last Update Submit

June 4, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Cardiopulmonary function

    using Cardiopulmonary exercise testing (CPET)

    at day 28 and 90 after positive in COVID-19 testing

  • Patient's quality of life

    using the The World Health Organization Quality of Life (WHOQOL-BREF-THAI) 26 items; the final score ranges from 24-120; higher score means participants satisfied with the quality of life.

    at day 3 and 21 after positive in COVID-19 testing

  • Functional capacity

    using Duke Activity status index The final score ranges between zero and 58.2 points; The higher the score, the better the functional capacity.

    at day 3 and 21 after positive in COVID-19 testing

  • Anxiety and depression

    using Hospital Anxiety and Depression Scale (HADS) The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

    at day 3 and 21 after positive in COVID-19 testing

  • Insomnia

    using Insomnia Severity Index (ISI) The final score ranges between zero and 28 points. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

    at day 3 and 21 after positive in COVID-19 testing

  • Cognitive function

    using Thai Mental State Examination The final score ranges between zero and 30 points. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.

    at day 3 and 21 after positive in COVID-19 testing

  • Muscle strength

    using 1-minute sit to stand

    at day 3 and 21 after positive in COVID-19 testing

Study Arms (2)

Control group

NO INTERVENTION

Receive an advice and a leaflet for cardiopulmonary rehabilitation.

Physiotherapy group

EXPERIMENTAL

Receive the physical therapy training via video call (Pulmonary training, Calisthenic exercise, Upper and lower limbs strengthening exercise, Core stabilizer exercise, Aerobic exercise) at day 3, 6, 9, 12, 16, and 21 after positive in COVID-19 testing and also receive advise and a leaflet for cardiopulmonary rehabilitation.

Behavioral: Exercise training

Interventions

1. Physical therapy training via video call 2. An advise and a leaflet for cardiopulmonary rehabilitation

Physiotherapy group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-60 years old
  • Positive in COVID-19 testing
  • Good communication and understanding
  • Independent mobility

You may not qualify if:

  • Cannot complete the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulabhorn hospital

Lak Si, Bangkok, 10210, Thailand

Location

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pooriput Waongenngarm, PhD

    Chulabhorn Royal Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 9, 2024

Study Start

February 9, 2024

Primary Completion

June 1, 2024

Study Completion

June 4, 2024

Last Updated

June 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Due to the ethical restriction, investigators cannot share any individual participant data.

Locations