Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

NCT04961333 | Unknown

• 1 other identifier: Danderyd University Hospital
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Internet-based multidisciplinary interventions will be offered to participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.

Conditions

Long COVID-19

Keywords

COVID-19; rehabilitation; telemedicine; multidisciplinary

Outcome Measures

Primary Outcomes (2)

• Change in health-related quality of life measured by Short Form-36

  Important sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest)

  Investigators expect changes at 6 months follow-up after rehabilitation

• Changes in heart rate variability during physical tests

  Heart rate variability measured by puls oximeter during 2 physical tests

  Investigators expect normalisation at 6 months follow-up

Secondary Outcomes (2)

• Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders

  Investigators expect changes already at 6 months follow-up

• Changed functioning and activity

  Investigators expect normalisation at 6 months follow-up

Study Arms (2)

Rehabilitation group

EXPERIMENTAL

Rehabilitation group will be provided multidisciplinary interventions online and individually by ExorLive app. The screening with self-scored questionnaires and physical tests will be performed before and after 8 weeks rehabilitation.

Behavioral: Multidisciplinary Rehabilitation

Waiting list controls

NO INTERVENTION

Passive waiting list or control group, which will be offered to participate in rehabilitation after at least 8 weeks of waiting time. The group will fulfil screening twice, following the time schedule of intervention group. When invited to rehabilitation a new screening will be asked to be completed if the waiting time after the last screening will be longer than 2 weeks.

Interventions

Multidisciplinary Rehabilitation BEHAVIORAL

Body therapies to improve breathing, normalise dysfunction in the autonomic nervous system, relaxation, mindfulness, in some part Acceptance and Commitment Therapy given preferably through body therapies.

Also known as: Individually performed physical activity recorded into ExorLie app.

Rehabilitation group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed COVID-19 infection
• post-infection symptoms lasting longer than 3-6 months
• clinically stable persons regarding symtoms or other co-morbidities
• ability to participate in internet-based rehabilitation in group in Swedish.

You may not qualify if:

• uncertainty regarding covid-19 infection or co-morbidities started or exacerbated during the same time
• alcohol and drug abuse
• untreated psychiatric and somatic co-morbidities
• undergoing medical or psychotherapeutic treatment or rehabilitation which can interact with rehabilitation outcomes.

Sponsors & Collaborators

• Danderyd Hospital: lead
• St Göran Hospital, Stockholm: collaborator

Study Sites (1)

St Göran Hospital

Stockholm, 112 19, Sweden

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Indre Bileviciute-Ljungar, Associated professor

CONTACT

+46858703158; indre.ljungar@ki.se

Kristian Borg, professor

CONTACT

+46812355000; kristian.borg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor in rehabilitation medicine

Model Details: Intervention group and waiting list control group

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: July 14, 2021
• Study Start: April 23, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

SE (1)