Clinical trial NCT05254301: Nutrition and LOComotoric Rehabilitation in Long COVID-19
Official title: Faster Functional Performance Recovery After Individualized Nutrition Therapy Combined With a Patient-tailored Physical Rehabilitation Program Versus Standard Physiotherapy in Patients With Long COVID: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Nutrition
Pilot Study
Physical Therapy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2022-02-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 1-minute sit-to-stand (1-MSTS)
timeFrame: Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks
Secondary outcomes:
measure: Multi-dimensional Fatigue Inventor (MFI-20)
timeFrame: Change from Baseline MFI-20 at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: EuroQol five-dimensional (five-level version) (EQ-5D-5L)
timeFrame: Change from Baseline EQ-5D-5L at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Post-COVID-19 Functional Status (PCFS)
timeFrame: Change from Baseline PCFS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline HADS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Change from Baseline WPAI at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
Other outcomes:
measure: Muscle strength
timeFrame: Change from Baseline muscle strength at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Handgrip strength
timeFrame: Change from Baseline handgrip strength at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: 6-minute walk test (6-MWT)
timeFrame: Change from Baseline 6-MWT at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: modified Medial Research Council (mMRC)
timeFrame: Change from Baseline mMRC at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Barthel Index
timeFrame: Change from Baseline Barthel Index at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Adequacy of feeding
timeFrame: Change from Baseline Adequacy of feeding at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Phase angle
timeFrame: Change from Baseline phase angle at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
measure: Fat-to-fat free mass ratio
timeFrame: Change from Baseline fat-to-fat free mass ratio at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
Locations:
city: Brussel
country: Belgium
facility: Universitair ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Elisabeth De Waele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: