Improving Health Status in COVID-19 Long-Hauler

November 6, 2024 updated by: Marie Carmen Valenza, Universidad de Granada

Improving Health Status in COVID-19 Long-Hauler Through an Activity Coaching Programme: a Randomized Control Trial

This randomized clinical trial investigates the effects of a distance physical activity coaching program on the health of COVID-19 long-hauler. The study evaluates the impact of individualized coaching interventions to improve participants' physical activity and quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marie Carmen Valenza, PhD
  • Phone Number: 958 248035
  • Email: cvalenza@ugr.es

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Faculty of Health Sciences. University of Granada
        • Contact:
        • Contact:
          • Marie Carmen Valenza, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both sexes.
  • Agreed to participate.
  • Post COVID-19 condition patients meeting the WHO definition for this disease.
  • Sedentary patients according to the cut-off point of the International Physical Activity Questionnaire (IPAQ).

Exclusion Criteria:

  • Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
  • Cognitive impairment that prevented them from understanding and answering the questionnaires.
  • Patients suffering from a reinfection with SARS-CoV-2.
  • Patients with a history of severe or critical COVID-19 disease severity.
  • Patients participating in other studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard medical care and leaflet education
Other: Standard medical care and leaflet education
In addition to standard medical care, patients assigned to this group received a leaflet with information about the main post COVID-19 condition symptoms. This is a control group that was not controlled or monitored by a therapist.
Experimental: Activity Coaching Programme
Other: Activity Coaching Programme
The intervention will consist of individualized physical activity coaching sessions, which will take place twice a week for 8 weeks. These sessions will focus on encouraging progressive and personalized physical activity according to each participant's ability. The sessions will also include relaxation techniques, targeted ventilation and strategies to improve activity management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IPAQ (International Physical Activity Questionnaire)
Time Frame: Baseline and at 8 weeks at the end of the intervention
Baseline and at 8 weeks at the end of the intervention
EQ-5D (EuroQol-5 Dimensions)
Time Frame: Baseline and at 8 weeks at the end of the intervention
Baseline and at 8 weeks at the end of the intervention
PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame: Baseline and at 8 weeks at the end of the intervention
Baseline and at 8 weeks at the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Marie Carmen Valenza, PhD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 11, 2024

Primary Completion (Estimated)

January 11, 2025

Study Completion (Estimated)

January 20, 2025

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Estimated)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0102UG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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