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Post-COVID-19 SyndromeNCT06165978

Physical Activity Coaching in Patients with Post-COVID-19

A study testing Self-monitoring, Goal setting and review and Education in people with Post-COVID-19 Syndrome, run by University of Alcala at 1 site in Spain.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This randomized clinical trial aims to compare the effects of a 12-week behavioral physical activity intervention (i.e., physical activity coaching) with usual care (i.e., World Health Organization recommendations for being physically active) in patients with post-COVID-19 (i.e., patients who suffered from COVID-19 at… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-COVID-19 Syndrome
What is being tested?
Self-monitoring, Goal setting and review and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteSpain
Study dates
17 Apr 2024to 31 Dec 2027
Phase
Interventional
Are there results?
None posted in the registry

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

  • At least, 18 years of age.
  • Having been diagnosed of COVID-19, confirmed by a polymerase chain reaction [PCR] test or an antigen test, at one of the severity levels during the acute phase of the illness.
  • Presenting a diagnosis of post-COVID-19, persistent COVID, or long COVID, involving the persistence of symptoms for at least three months after the acute phase of the illness (i.e., to reduce variability in the diagnosis, it is proposed that symptom persistence be for at least 12 months).
  • Being included in a post-COVID-19 follow-up consultation (or another consultation - pulmonology, internal medicine - in the event of closure of a specific consultation) in the region of Madrid, Spain.
  • Stable condition of symptoms and comorbidities (i.e., no major change in clinical status).

Who cannot join

  • Presenting significant signs of cognitive decline, cardiovascular, neurological, and/or musculoskeletal disease that could hinder the performance of assessment tests and thus limit participation or pose a risk to their health.
  • Particularly presenting the following conditions: cognitive disorders such as sequelae of Alzheimer's disease, senile dementia; comprehension disorders such as Wernicke's aphasia; cognitive-motor disorders such as hemiparesis/hemiplegia due to stroke; musculoskeletal disorders such as non-healed fractures, external prostheses (including prosthetic limbs for amputees); cardiovascular disorders such as unstable angina, recent acute myocardial infarction, among others.
  • Medical history that interferes with the study's objectives or compromises its conclusions.
  • Any health issues that limit life expectancy to less than one year.
  • Medical, social, or geographical factor that may endanger the patient.
  • Psycho-physical inability to complete assessment tests and questionnaires.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Alcalá

    Alcalá de Henares, Madrid, 28805

Other trials in Spain

About this study

Official title: Physical Activity Coaching in Patients with Post-COVID-19. a Randomised Clinical Trial.

This randomized clinical trial aims to compare the effects of a 12-week behavioral physical activity intervention (i.e., physical activity coaching) with usual care (i.e., World Health Organization recommendations for being physically active) in patients with post-COVID-19 (i.e., patients who suffered from COVID-19 at any degree of severity in acute phase and experience symptoms for at least three months after discharge).

This study aims to answer the following question:

  1. Which are the effects of a physical activity coaching intervention compared with usual care in patients post-COVID-19 in the short-, middle- and long-term?
Read the detailed description

Patients will be invited to participate via phone calls, and those interested will be scheduled to obtain their written informed consent and undergo a baseline assessment.

Afterwards, they will be randomized into an experimental group and a control group. In the experimental group, a 12-week/three-month physical activity coaching intervention will be conducted, while the control group will receive usual care. A post-intervention assessment will then be carried out, followed by follow-ups at 6 and 12 months after the baseline assessment.

The assessment will consist of a series of tests and questionnaires to record the following data: physical activity, functional capacity, muscle strength, health-related quality of life, symptoms, lung function, sociodemographic, and anthropometric data.

Being tested
Self-monitoring, Goal setting and review, Education, Feedback, Contact
Keywords
physical activity, physical activity coaching, post-COVID-19
Medical subject headings
Post-Acute COVID-19 Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-monitoringBehavioural

    pedometer/activity band provided to each participant

  • Goal setting and reviewBehavioural

    Goal setting and review (weekly: +15% of the previous week's average daily steps or walking time, or +1000 steps/day or +10 minutes walking - to be specified)

  • EducationBehavioural

    Educational sessions (face-to-face: providing a manual/explanatory brochure of the intervention; remote: addressing symptom pathophysiology, symptom management, among other topics)

  • FeedbackBehavioural

    Daily or weekly feedback for patients (emotional/social support)

  • ContactBehavioural

    Contact with patients (face-to-face: for assessments; on remote: 1 -messages: for therapists' daily/weekly feedback or patient reports; 2 - calls: to adjust weekly goals or address doubts or issues)

  • ExerciseBehavioural

    Exercise based on patient preference, explaining how to identify moderate intensity (HRmax=64-76%, Borg 3-6) or vigorous intensity (HRmax=77-95%; Borg 7-8) and monitoring safety parameters (StO2>88%, HRmax<96%, Borg<9)

  • ReportBehavioural

    Daily or weekly reporting for therapists (messages)

  • Social supportBehavioural

    Support meetings (in-person), parallel to educational sessions

  • Group activitiesBehavioural

    Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)

  • World Health Organization recommendations for being physically activeBehavioural

    World Health Organization's recommendations to maintain physical activity levels (i.e., 150-300 minutes/week of moderate to vigorous intensity physical activity; a weekly average of 10,000 steps/day or 100-120 minutes walking, which implies maintaining a pace of 100 steps/minute - corresponding to the average cadence across different age and gender groups).

Study groups in NCT06165978
Study groupRoleWhat they receive
Physical activity coaching - Experimental groupExperimentalThe experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
Receives: Behavioral: Self-monitoring; Behavioral: Goal setting and review; Behavioral: Education; Behavioral: Feedback; Behavioral: Contact; Behavioral: Exercise; Behavioral: Report; Behavioral: Social support; Behavioral: Group activities; Behavioral: World Health Organization recommendations for being physically active
Usual care - Control groupOtherThe control group intervention runs parallel to the experimental group for 12 weeks, conducted at participants' home or within the community, and consists of usual management (i.e., World Health Organization's recommendations for being physically active).
Receives: Behavioral: World Health Organization recommendations for being physically active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months

    Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends.

    The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported.

    Using a statistical package and an appropriate algorithm, we will extract: the total daily step count (steps/day).

    Measured: Baseline, 12 weeks, 6 months and 12 months

  2. Change in Physical activity (PA) patterns (time spent in light PA per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months

    Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends.

    The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported.

    Using a statistical package and an appropriate algorithm, we will extract: the total time spent in light PA per day (hours and minutes per day)

    Measured: Baseline, 12 weeks, 6 months and 12 months

  3. Change in Physical activity (PA) patterns (time spent in moderate-to-vigorous PA per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months

    Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends.

    The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported.

    Using a statistical package and an appropriate algorithm, we will extract: the total time spent in moderate-to-vigorous PA per day (hours and minutes per day)

    Measured: Baseline, 12 weeks, 6 months and 12 months

  4. Change in Physical activity (PA) patterns (time in sedentary behaviour -lying or sitting- per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months

    Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends.

    The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported.

    Using a statistical package and an appropriate algorithm, we will extract: the total time in sedentary behaviour -lying or sitting- per day (hours and minutes per day)

    Measured: Baseline, 12 weeks, 6 months and 12 months

  5. Change in functional capacity (six-minute walking test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Six-minute walking test/distance [6MWT/6MWD]. Patients will be asked to walk as far as possible in six minutes along a flat 30m corridor. Standardised instructions and encouragement will be given during the test, following European Respiratory Society/American Thoracic Society (ERS/ATS) statement.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  6. Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    One-minute sit-to-stand [1minSTS]. Patients will sit and stand from a chair, without the aid of the upper limbs, many times as they can in a 1-min bout. Afterwards, the results will be compared to age- and sex-matched reference values.

    Measured: Baseline, 12 weeks, 6 months and 12 months

Secondary outcomes (19)

  1. Change in isometric quadriceps strength from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Isometric quadriceps strength (dynamometer). A hand-held dynamometer will be used to assess isometric strength of the dominant leg. Participants will be seated at the edge of a treatment table, positioned at 60º of knee flexion, and with arms across the chest. The dynamometer will be positioned two fingers width above the lateral malleolus on the anterior aspect of the tibia.

    Four warm-ups will be allowed, on each at 25, 50, 75, and 100% of perceived effort, gradually building up to a maximal effort over 1 to 2 seconds.

    The tester will perform two make tests with the subject exerting 100% effort for 3 seconds. Average peak force of the two trials will be used to determine quadriceps muscle performance. The make test will entail the examiner giving appropriate resistance to the muscle force in order to ensure isometric conditions.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  2. Change in handgrip force from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Handgrip force (dynamometer). A hand-held dynamometer will be used to measure isometric strength of the grip. Participants will be seated on a straight back chair with both feet flat on the floor. Arm positioning will be demonstrated by the examiner: the tested arm (dominant) will have the elbow bended to 90º, the forearm and wrist in neutral position, and the fingers flexed as needed for a maximal contraction, while the not-tested arm will assume an adducted and neutrally rotated shoulder position.

    Subjects will be instructed to breathe in through their nose and blow out through pursed lips while making a maximum grip effort. At this time, a verbal encouragement will be given by the examiner (e.g., "Squeeze! Harder! Harder! Relax!").

    Rest will be allowed between each grip assessment, no longer than four minutes. The average score among three trials will be recorded.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  3. Change in maximal inspiratory and expiratory pressures from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Maximal respiratory pressures (PImax, PEmax) will be measured using a portable digital manometer; and assessed according to the European Respiratory Society/American Thoracic Society (ERS/ATS) recommendations [31] and following the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) protocol.

    Then, the highest value of 3 attempts will be selected to obtain a reliable average, excluding pressure peaks lower than one second. Participants will be asked to sit with their neck and chest in an upright position and their feet flat on the floor. The results will be read using the current reference values in Spanish population provided by Lista-Paz et al. 2023.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  4. Change in health-related quality of life from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Health-related quality of life [EuroQoL-five dimensions-five levels (EQ-5D-5L) questionnaire). The EQ-5D-5L consists of two parts: the descriptive system and a visual analogue scale (VAS). The descriptive system addresses five different dimensions (mobility, self-care, usual activities. pain/discomfort, and anxiety/depression), each with a five-point Likert-scale; the answering pattern can be transferred to a utility between 0 and 1 (the higher the better) by distinct (nation-specific) scoring algorithms. On the other hand, the VAS allows valuing current health on a 0-100 mm scale, with higher values indicating better health.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  5. Change in dyspnoea symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Dyspnea - modified Medical Research Council (mMRC) scale. The mMRC dyspnea scale consists of five grades of increasing severity. A higher score indicates a greater impact of dyspnea on activities of daily life.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  6. Change in fatigue symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.

    The FACIT-F scale consists of many items to produce a global score, and each item can be scored from 0 to 4 (from "not at all" to "very much"). It covers different aspects of fatigue (physical, functional, emotional, and social consequences) with regard to the previous seven days. A higher score reflects less fatigue.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  7. Change in anxiety and depression symptoms from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months

    Anxiety and depression-The Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales (HADS-A, for anxiety disorders, and HADS-D, for depression) both containing seven intermingled items. A higher score implies a more severe case.

    Measured: Baseline, 12 weeks, 6 months and 12 months

  8. Forced expiratory volume in one second (FEV1) assessed using spirometry at baseline (pre-intervention).

    Forced expiratory volume in the first second (FEV1 in milliliters)

    Measured: Baseline.

  9. Forced expiratory volume in one second percentage predicted (FEV1%predicted) assessed using spirometry at baseline (pre-intervention).

    Forced expiratory volume in the first second (FEV1) as percentage predicted

    Measured: Baseline.

  10. Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention).

    Forced vital capacity (FVC in milliliters)

    Measured: Baseline.

  11. Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention).

    Forced vital capacity (FVC) as percentage predicted

    Measured: Baseline.

  12. Ratio between Forced expiratory volume in one second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (pre-intervention).

    Ratio between Forced expiratory volume in the first second and Forced vital capacity (FEV1/FVC, percentage)

    Measured: Baseline.

  13. Sociodemographics (age) at baseline (pre-intervention).

    Sociodemographics (age in years).

    Measured: Baseline.

  14. Sociodemographics (sex) at baseline (pre-intervention).

    Sociodemographics (sex, assessed as male/female).

    Measured: Baseline.

  15. Anthropometrics (height) at baseline (pre-intervention).

    Anthropometrics (height in meters).

    Measured: Baseline.

  16. Anthropometrics (weight) at baseline (pre-intervention).

    Anthropometrics (weight in kilograms).

    Measured: Baseline.

  17. Anthropometrics (body mass index - BMI) at baseline (pre-intervention).

    Weight and height will be combined to report BMI in kilograms/meters^2 (kg/m^2).

    Measured: Baseline.

  18. Proportion of participants with a diagnosed disease according to the International Classification of Diseases (ICD) at baseline (pre-intervention)

    Absolute and relative frequencies of any diagnosed disease will be reported using the International Classification of Diseases (ICD).

    Measured: Baseline.

  19. Proportion of participants following any pharmacological treatment or plan, as classified by the Anatomical Therapeutic Chemical (ATC) classification system at baseline (pre-intervention).

    Absolute and relative frequencies of any pharmacological treatment will be reported in accordance with the Anatomical Therapeutic Chemical (ATC) classification system.

    Measured: Baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start17 Apr 2024
  3. Primary completion31 Jan 2025
  4. Study completion31 Dec 2027 (estimated)

Why it stopped: In response to recruitment difficulties, the study has been reclassified as a pilot phase. This adjustment will allow for an in-depth evaluation of feasibility and procedural refinements before considering a larger-scale trial.

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165978
Sponsor's protocol ID
CEID/2023/3/072
Status last verified
Feb 2025
First submitted
11 Dec 2023
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared after finalizing the draft of the database (at the end of follow-up), and only upon a formal request to the study principal investigator.

Publications

  • Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.

    PubMed 23397303

  • Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.

    PubMed 24603844

  • Taraldsen K, Chastin SF, Riphagen II, Vereijken B, Helbostad JL. Physical activity monitoring by use of accelerometer-based body-worn sensors in older adults: a systematic literature review of current knowledge and applications. Maturitas. 2012 Jan;71(1):13-9. doi: 10.1016/j.maturitas.2011.11.003. Epub 2011 Nov 30.

    PubMed 22134002

  • Demeyer H, Burtin C, Hornikx M, Camillo CA, Van Remoortel H, Langer D, Janssens W, Troosters T. The Minimal Important Difference in Physical Activity in Patients with COPD. PLoS One. 2016 Apr 28;11(4):e0154587. doi: 10.1371/journal.pone.0154587. eCollection 2016.

    PubMed 27124297

  • Gardner AW, Montgomery PS, Wang M, Shen B. Minimal clinically important differences in daily physical activity outcomes following supervised and home-based exercise in peripheral artery disease. Vasc Med. 2022 Apr;27(2):142-149. doi: 10.1177/1358863X211072913. Epub 2022 Feb 15.

    PubMed 35164605

  • Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

    PubMed 25359355

  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PubMed 7624188

  • Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.

    PubMed 27799759

  • Deones VL, Wiley SC, Worrell T. Assessment of quadriceps muscle performance by a hand-held dynamometer and an isokinetic dynamometer. J Orthop Sports Phys Ther. 1994 Dec;20(6):296-301. doi: 10.2519/jospt.1994.20.6.296.

    PubMed 7849749

  • Oliveira A, Rebelo P, Paixao C, Jacome C, Cruz J, Martins V, Simao P, Brooks D, Marques A. Minimal Clinically Important Difference for Quadriceps Muscle Strength in People with COPD following Pulmonary Rehabilitation. COPD. 2021 Feb;18(1):35-44. doi: 10.1080/15412555.2021.1874897. Epub 2021 Feb 3.

    PubMed 33533285

  • Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.

    PubMed 18796752

  • Bohannon RW. Minimal clinically important difference for grip strength: a systematic review. J Phys Ther Sci. 2019 Jan;31(1):75-78. doi: 10.1589/jpts.31.75. Epub 2019 Jan 10.

    PubMed 30774209

  • Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish.

    PubMed 37839949

  • Szentes BL, Kreuter M, Bahmer T, Birring SS, Claussen M, Waelscher J, Leidl R, Schwarzkopf L. Quality of life assessment in interstitial lung diseases:a comparison of the disease-specific K-BILD with the generic EQ-5D-5L. Respir Res. 2018 May 25;19(1):101. doi: 10.1186/s12931-018-0808-x.

    PubMed 29801506

  • Garcia-Gordillo MA, Adsuar JC, Olivares PR. Normative values of EQ-5D-5L: in a Spanish representative population sample from Spanish Health Survey, 2011. Qual Life Res. 2016 May;25(5):1313-21. doi: 10.1007/s11136-015-1164-7. Epub 2015 Oct 19.

    PubMed 26482825

Questions about this trial

What is this clinical trial studying?

A study testing Self-monitoring, Goal setting and review and Education in people with Post-COVID-19 Syndrome, run by University of Alcala 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 5 inclusion and 6 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: paused, as of the sponsor's last update on 21 Feb 2025. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months (time frame: Baseline, 12 weeks, 6 months and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06165978, which also lists 20 linked publications.

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 21 Feb 2025.

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