Nutrition and LOComotoric Rehabilitation in Long COVID-19

NCT ID: NCT05254301

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-24
• Study Completion Date: 2024-01-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Personalized multimodal treatment

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

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: OTHER

This personalised multimodal treatment considers evidence- and practice-based elements (e.g., self-management, individual guidance \& follow-up, low-threshold activities, homebased functional training \& better follow-up guidance afterwards).

Standard care

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

Group Type: ACTIVE_COMPARATOR

Intervention group

Intervention Type: OTHER

This personalised multimodal treatment considers evidence- and practice-based elements (e.g., self-management, individual guidance \& follow-up, low-threshold activities, homebased functional training \& better follow-up guidance afterwards).

Interventions

Intervention group

This personalised multimodal treatment considers evidence- and practice-based elements (e.g., self-management, individual guidance \& follow-up, low-threshold activities, homebased functional training \& better follow-up guidance afterwards).

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth De Waele

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth De Waele, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Universitair ziekenhuis Brussel

Brussels, , Belgium

Countries

Belgium

References

Roggeman S, Jimenez Garcia BG, Leemans L, Demol J, Geers J, De Smedt A, Putman K, Schiltz M, Beckwee D, De Waele E. 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. Pilot Feasibility Stud. 2023 Sep 28;9(1):166. doi: 10.1186/s40814-023-01392-1.

Reference Type: DERIVED

PMID: 37759324 (View on PubMed)

Other Identifiers

LCOV21-1306

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022-EDW-01

Identifier Type: -

Identifier Source: org_study_id