Physiotherapy in Post COVID-19 Syndrome Patients

NCT ID: NCT05477199

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-09-22

Brief Summary

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Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of a cognitive behavioral principles-based treatment program in fear avoidance beliefs, disability, pain catastrophizing and pain interference.

Detailed Description

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Conditions

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Post-COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Cognitive behavioral principles-based treatment program group

Group Type EXPERIMENTAL

Cognitive behavioral principles-based treatment program

Intervention Type OTHER

The treatment protocol had a total duration of 6 weeks. Two sessions were conducted each week, the first being a group session lasting 1.5 hours and the second an individual session lasting 45 minutes. During the group sessions, emotional disclosure and sharing of the experiences of patients with post COVID-19 syndrome were encouraged. During the individual sessions, a strong relationship was developed between the patient and the healthcare professional, with the healthcare professional helping the patient develop self-efficacy, thought monitoring, helpful self-talk, and reflection on changes in activity levels throughout the program.

Control group

Group Type ACTIVE_COMPARATOR

Control intervention

Intervention Type OTHER

Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional.

Interventions

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Cognitive behavioral principles-based treatment program

The treatment protocol had a total duration of 6 weeks. Two sessions were conducted each week, the first being a group session lasting 1.5 hours and the second an individual session lasting 45 minutes. During the group sessions, emotional disclosure and sharing of the experiences of patients with post COVID-19 syndrome were encouraged. During the individual sessions, a strong relationship was developed between the patient and the healthcare professional, with the healthcare professional helping the patient develop self-efficacy, thought monitoring, helpful self-talk, and reflection on changes in activity levels throughout the program.

Intervention Type OTHER

Control intervention

Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes.
* Agreed to participate.
* Post COVID-19 patients meeting the WHO definition for this disease.

Exclusion Criteria

* Neurological or orthopaedic pathologies that limited voluntary movement.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients suffering from a reinfection with SARS-CoV-2.
* Patients who had been hospitalized due to COVID-19 infection.
* Patients who had pre-existing chronic pain according to the current IASP definition.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Carmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Faculty of Health Sciences. University of Granada.

Granada, Granada, Spain

Site Status

Countries

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Spain

Other Identifiers

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DF0098UG

Identifier Type: -

Identifier Source: org_study_id