Physiotherapy in Post COVID-19 Syndrome Patients

NCT05477199 | Completed

• 1 other identifier: DF0098UG
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (2)

• Fear-avoidance belief changes

  Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).

  Baseline

• Fear-avoidance belief changes

  Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).

  At 6 weeks at the end of the intervention

Secondary Outcomes (8)

• Changes in functionality

  Baseline

• Changes in functionality

  At 6 weeks at the end of the intervention

• Changes in pain catastrophizing

  Baseline

• Changes in pain catastrophizing

  At 6 weeks at the end of the intervention

• Changes in pain interference

  Baseline

Study Arms (2)

Cognitive behavioral principles-based treatment program group

EXPERIMENTAL

Other: Cognitive behavioral principles-based treatment program

Control group

ACTIVE COMPARATOR

Other: Control intervention

Interventions

Cognitive behavioral principles-based treatment program 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.

Cognitive behavioral principles-based treatment program group

Control intervention 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.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: August 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 22, 2022
• Last Updated: November 27, 2023

Record last verified: 2022-07

Locations

ES (1)