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NCT Number: NCT06679218

Improving Health Status in COVID-19 Long-Hauler

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.

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Key information

Conditions

Post COVID-19 Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences. University of Granada

Granada, 18071, Spain

Location contact

Marie Carmen Valenza, PT

CONTACT

[email protected]

958 248035

Marie Carmen Valenza, PT, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. IPAQ (International Physical Activity Questionnaire)

    Time frame: Baseline and at 8 weeks at the end of the intervention

  2. EQ-5D (EuroQol-5 Dimensions)

    Time frame: Baseline and at 8 weeks at the end of the intervention

  3. PROMIS (Patient-Reported Outcomes Measurement Information System)

    Time frame: Baseline and at 8 weeks at the end of the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Carmen Valenza, PhD

CONTACT

[email protected]

958 248035

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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