Post COVID-19 ConditionNCT06679218
Improving Health Status in COVID-19 Long-Hauler
A study testing Activity Coaching Programme and Standard medical care and leaflet education in people with Post COVID-19 Condition, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Activity Coaching Programme and Standard medical care and leaflet education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of Health Sciences. University of Granada
Granada, Granada, 18071
Marie Carmen Valenza, PT, 958 248035, cvalenza@ugr.es
Marie Carmen Valenza, PT, PhD
About this study
Official title: 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.
- Conditions
- Post COVID-19 Condition
- Being tested
- Activity Coaching Programme, Standard medical care and leaflet education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Coaching ProgrammeOther
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 educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Activity Coaching Programme | Experimental | Not described Receives: Other: Activity Coaching Programme |
| Standard medical care and leaflet education | Active comparator | Not described Receives: Other: Standard medical care and leaflet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPAQ (International Physical Activity Questionnaire)
Measured: Baseline and at 8 weeks at the end of the intervention
EQ-5D (EuroQol-5 Dimensions)
Measured: Baseline and at 8 weeks at the end of the intervention
PROMIS (Patient-Reported Outcomes Measurement Information System)
Measured: Baseline and at 8 weeks at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Nov 2024 (estimated)
- Primary completion11 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679218
- Sponsor's protocol ID
- DF0102UG
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Status in COVID-19 Long-Hauler Through an Activity Coaching Programme: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06679218
- Acronym / sponsor ID
- DF0102UG
- Conditions
- Post COVID-19 Condition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 11 Nov 2024 (estimated)
- Primary completion
- 11 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity Coaching Programme | Experimental | Other: Activity Coaching Programme |
| Standard medical care and leaflet education | Active comparator | Other: Standard medical care and leaflet education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity Coaching ProgrammeThe 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. | Other | Activity Coaching Programme |
| Standard medical care and leaflet educationIn 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. | Other | Standard medical care and leaflet education |
Primary outcome
IPAQ (International Physical Activity Questionnaire)
Time frame: 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
PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline and at 8 weeks at the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Coaching Programme and Standard medical care and leaflet education in people with Post COVID-19 Condition, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958 248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPAQ (International Physical Activity Questionnaire) (time frame: Baseline and at 8 weeks at the end of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.