Improving Health Status in COVID-19 Long-Hauler

NCT06679218 | Not Yet Recruiting

• 1 other identifier: DF0102UG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post COVID-19 Condition

Outcome Measures

Primary Outcomes (3)

• IPAQ (International Physical Activity Questionnaire)

  Baseline and at 8 weeks at the end of the intervention

• EQ-5D (EuroQol-5 Dimensions)

  Baseline and at 8 weeks at the end of the intervention

• PROMIS (Patient-Reported Outcomes Measurement Information System)

  Baseline and at 8 weeks at the end of the intervention

Study Arms (2)

Activity Coaching Programme

EXPERIMENTAL

Other: Activity Coaching Programme

Standard medical care and leaflet education

ACTIVE COMPARATOR

Other: Standard medical care and leaflet education

Interventions

Activity Coaching Programme OTHER

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.

Activity Coaching Programme

Standard medical care and leaflet education OTHER

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.

Standard medical care and leaflet education

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 condition patients meeting the WHO definition for this disease.
• Sedentary patients according to the cut-off point of the International Physical Activity Questionnaire (IPAQ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada

Granada, Granada, 18071, Spain

Location

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

958 248035; cvalenza@ugr.es

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: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: November 11, 2024
• Primary Completion: January 11, 2025
• Study Completion: January 20, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

ES (1)