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Covid19WAYRANCT04649736

Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients

A study testing Respiratory and psychological rehabilitation in people with Covid19 and Respiratory Disease, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Respiratory and psychological rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 sitePeru
Study dates
26 Oct 2020to 19 Jun 2021
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years
  • Be discharged from hospitalization with a COVID-19 confirmed diagnosis
  • Be able of understanding study procedures
  • Be able to give informed consent
  • Required oxygen flow greater than 6lt/min or through a high flow device at any time during hospitalization
  • Have been evaluated by the rehabilitation service at least once during the hospitalization

Who cannot join

  • Contraindications to six-minute walk test
  • Contraindications to spirometry
  • Complications during the baseline six-minute walk test
  • Have neurological pathology, neuropathy, limb dysfunction, or other underlying physical disability that makes physical exercise impossible
  • Be pregnant or breastfeeding
  • Do not have access to the Internet or a telephone line
Show all 12Show fewer
  • Have previous lung diseases like asthma, COPD, fibrosis, or tuberculosis
  • Moderate or severe heart disease (Grade III or IV, New York Heart Association)
  • Have had another severe disease in the last six months
  • Severe depression or suicidal intention
  • Be taking any medication for depression, anxiety, or other medication prescribed by a psychiatrist prior to the onset of a COVID-19 condition
  • Have cognitive impairment or sensory disturbance

Trial locations and contacts

1 site in 1 country.

Peru1 site
  • Hospital Nacional Cayetano Heredia

    Lima, 15102

Other trials in Peru

About this study

Official title: Prevalence of Altered Pulmonary Function Post-infection by COVID-19 and Impact of Participation in a Pilot Program of Comprehensive Rehabilitation in the Short and Medium-term

Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.

Read the detailed description

In Peru, almost one million persons have survived COVID-19 and initial reports indicate that could exist long-term health damage. This study aims to assess the efficacy of a 6-week rehabilitation program following hospital discharge for patients who had severe COVID-19. The program includes 12 sessions of home-based respiratory therapy that the patient will carry out with a physiotherapist and 7 sessions of telephone-based psychological support bring by a psychologist.

Being tested
Respiratory and psychological rehabilitation
Keywords
COVID-19, Mental Health, Respiratory Function Tests, Physical and Rehabilitation Medicine, Quality of Life
Medical subject headings
COVID-19, Respiration Disorders, Mental Disorders, Psychological Well-Being

What participants receive

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

  • Respiratory and psychological rehabilitationOther

    Respiratory rehabilitation consists of 12 sessions of respiratory and physical exercises that patients perform at home with the help of a physiotherapist. Sessions have 1 hour of duration and are performing twice a week. Exercises include (1) Training of the respiratory muscles through pursed-lip breaths. (2) Effective cough exercises. (3) Diaphragmatic contractions in a supine position with a lightweight placed on the anterior abdominal wall. (4) Stretching exercise of extremities and the back.

    The psychological support consists of 1 session to make the psychological history of the participant, and 6 sessions of emotion-centered problem-solving therapy, with cognitive-behavioral components and psychological management of emergencies and crises. These sessions have a 1-hour duration and are telephone-provided once a week by psychologists following the guidelines of the Inter-Agency Standing Committee on Mental Health and Psychosocial Support in Humanitarian and Disaster Emergencies.

Study groups in NCT04649736
Study groupRoleWhat they receive
Home-based Respiratory Physiotherapy and Telephone-Based Psychological SupportExperimentalParticipants in the intervention arm will receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital. Additionally, these participants will receive the intervention program that involves home-based respiratory physiotherapy and telephone-based psychological support for 6 weeks.
Receives: Other: Respiratory and psychological rehabilitation
ControlNo interventionParticipants in the control arm will only receive the conventional care given by the hospital that consists of discharged recommendations and a follow-up plan through telephone calls to verify treatment compliance. Discharged recommendations include performing respiratory exercises at home and medication. There is no plan for diagnosing mental illness or a strategy for respiratory o psychological rehabilitation at the hospital.

What is being measured

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

  1. Six minute walk distance

    Distance walked during 6-minutes (meters)

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

Secondary outcomes (8)
  1. Forced expiratory volume in the first second

    Measured in milliliters by dynamic spirometry

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  2. Forced Vital Capacity

    Measured in milliliters by dynamic spirometry

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  3. Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire

    The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better health-related quality of life

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  4. Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire

    EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually.

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  5. Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9)

    The Patient Health Questionnaire-9 (PHQ-9) consists of nine items covering the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. A greater score means worse depressive symptoms.

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  6. Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire

    The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. A higher score means worse anxiety symptoms.

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  7. Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire.

    IES-R consists of 21 items covering the DSM-IV criteria for PTSD. Score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress).

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

  8. Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ)

    The SGRQ scores from 0 (no impairment of quality of life by respiratory diseases/symptoms) to 100 (highest impairment of quality of life by respiratory diseases/symptoms)

    Measured: Change from baseline measure at hospital discharge to week 7 and 12

Timeline

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

  1. First posted2 Dec 2020
  2. Study start26 Oct 2020
  3. Primary completion19 Jun 2021
  4. Study completion19 Jun 2021

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
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649736
Sponsor's protocol ID
202852
Acronym
WAYRA
Status last verified
May 2021
First submitted
30 Nov 2020
Last updated
3 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Results will be published in an indexed peer-review journals.

Publications

  • Spagnolo P, Balestro E, Aliberti S, Cocconcelli E, Biondini D, Casa GD, Sverzellati N, Maher TM. Pulmonary fibrosis secondary to COVID-19: a call to arms? Lancet Respir Med. 2020 Aug;8(8):750-752. doi: 10.1016/S2213-2600(20)30222-8. Epub 2020 May 15. No abstract available.

    PubMed 32422177
  • Xie L, Liu Y, Xiao Y, Tian Q, Fan B, Zhao H, Chen W. Follow-up study on pulmonary function and lung radiographic changes in rehabilitating severe acute respiratory syndrome patients after discharge. Chest. 2005 Jun;127(6):2119-24. doi: 10.1378/chest.127.6.2119.

    PubMed 15947329
  • Das KM, Lee EY, Singh R, Enani MA, Al Dossari K, Van Gorkom K, Larsson SG, Langer RD. Follow-up chest radiographic findings in patients with MERS-CoV after recovery. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):342-349. doi: 10.4103/ijri.IJRI_469_16.

    PubMed 29089687
  • Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun.

    PubMed 32381497
  • Yang LL, Yang T. Pulmonary rehabilitation for patients with coronavirus disease 2019 (COVID-19). Chronic Dis Transl Med. 2020 May 14;6(2):79-86. doi: 10.1016/j.cdtm.2020.05.002. eCollection 2020 Jun.

    PubMed 32411496
  • Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.

    PubMed 32379637
  • Jang MH, Shin MJ, Shin YB. Pulmonary and Physical Rehabilitation in Critically Ill Patients. Acute Crit Care. 2019 Feb;34(1):1-13. doi: 10.4266/acc.2019.00444. Epub 2019 Feb 28.

    PubMed 31723900
  • Soriano-Moreno AN, Flores EC, Hartinger SM, Mallma CY, Diaz AA, Gianella GE, Galvez-Buccollini JA, Coico-Lama AH, Malaga G, Fajardo E, Paredes-Angeles R, Otazu-Alfaro S, Lescano AG, Checkley W; WAYRA Trial Investigators. Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 24;11(10):e36001. doi: 10.2196/36001.

    PubMed 36108135

Questions about this trial

What is this clinical trial studying?

A study testing Respiratory and psychological rehabilitation in people with Covid19 and Respiratory Disease, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.

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 6 inclusion and 12 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: finished, as of the sponsor's last update on 3 Dec 2021. 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 Peru. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Six minute walk distance (time frame: Change from baseline measure at hospital discharge to week 7 and 12). 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 NCT04649736, which also lists 8 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 3 Dec 2021.

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