Nutrition and LOComotoric Rehabilitation in Long COVID-19 (UNLOCK)

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: COVID-19

Treatments: Other: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT05254301

LCOV21-1306 (Other Grant/Funding Number)

2022-EDW-01

Details and patient eligibility

About

Long COVID is a new phenomenon, in which individuals who experienced a SARS-CoV-2 infection still experience one or more symptoms, such as exercise intolerance, fatigue and/or muscle pains in addition to other COVID-related symptoms, weeks to months after initial infection.

The aim of this pilot-study is to learn about which complaints patients continue to experience after their infection and how this affects their lives to a greater or lesser extent and whether a patient-tailored physical rehabilitation programme combined with individualised nutritional therapy leads to a faster recovery compared to a classic exercise program with the physiotherapist.

Full description

The rapid spread of SARS-CoV-2 virus has already led to more than 212 million confirmed cases. The acute phase of infection resulted in variable clinical presentations, from asymptomatic to severe illness requiring admission at an intensive care unit. As the COVID-19 pandemic evolves, long-term symptoms and functional problems related to the SARS-CoV-2 infection reached the surface. Approximately 5-10% of the infected people experience prolonged symptoms with predominant symptoms being overall reduced physical capacity, fatigue and muscle weakness. Exertional intolerance/post-exertional malaise is also frequently seen.

A growing group of patients experience persisting symptoms after the initial infection and these can have significant impact on daily functioning and quality of life. These patients feel 'abandoned' by healthcare providers and receive limited or conflicting advice. Treatment modalities for patients with long COVID have up and till now been scarcely investigated because there is insufficient understanding of the underlying mechanisms. However, most patients seek care and the majority of them receive physiotherapy/rehabilitation in one form or another in the 3 to 6 months after onset. Unfortunately, this seems not to be enough, on the contrary, patients seem to experience even more difficulties. Nutrition-wise, after highly prevalent weight loss in the active phase of COVID-19, challenges remain to improve protein intake and gain muscle mass. This stresses the need for a multidisciplinary approach and social support.

The aim of the current study is to investigate if a patient-tailored physical rehabilitation programme combined with nutritional optimisation with individualised therapy and counselling may lead to a faster improvement of functional performance compared to a standard physiotherapy programme in patients suffering from long-term effects (> 12 weeks) of COVID-19.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and sign written consent in Dutch, French or English
• Laboratory (PCR and/or serology) confirmed infection with SARS-CoV-2 less than 12 months ago
• Persisting functional difficulties and symptoms: exercise intolerance and/or fatigue and/or muscle pain beyond 12 weeks beside other COVID-related symptoms (e.g., loss of taste and/or smell)
• Patient affiliated to a social security system

Exclusion criteria

• Patients unable to comprehend oral and/or written instructions, questionnaires in English, French or Dutch.
• Patient currently suffers from any other disease beside long COVID that could explain the symptoms (e.g., fibromyalgia, Sjögren disease, severe anaemia...)
• Patient is unable to undergo a rehabilitation programme due to comorbidities (e.g., major cardiovascular disease such as myocarditis or severe dementia), as decided on by the medical study team members.
• Patient currently benefiting from physiotherapy sessions with focus on motor and/or respiratory therapy for COVID-19 or any other unrelated disease
• Patients with metabolic disorders or severe gastro-intestinal conditions (e.g. short bowel syndrome)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Personalized multimodal treatment

Experimental group

Description:

A combination of biometric parameter oriented nutritional counseling and a tailored physical training program.

Treatment:

Other: Intervention group

Standard care

Active Comparator group

Description:

Physiotherapy with standard care advice for gradual cardiorespiratory and resistance training. (In this standard care setting, nutritional screening nor counseling is included.)

Treatment:

Other: Intervention group