Nutrition and LOComotoric Rehabilitation in Long COVID-19

NCT05254301 | Completed DMC

• 2 other identifiers: 2022-EDW-01LCOV21-1306
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Nutrition; Pilot Study; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 1-minute sit-to-stand (1-MSTS)

  Testing of endurance and muscle strength of the lower extremities (standing up from a sitting position for as many repetitions as possible during 1 minute)

  Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks

Secondary Outcomes (5)

• Multi-dimensional Fatigue Inventor (MFI-20)

  Change from Baseline MFI-20 at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

• EuroQol five-dimensional (five-level version) (EQ-5D-5L)

  Change from Baseline EQ-5D-5L at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

• Post-COVID-19 Functional Status (PCFS)

  Change from Baseline PCFS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

• Hospital Anxiety and Depression Scale (HADS)

  Change from Baseline HADS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

• Work Productivity and Activity Impairment (WPAI)

  Change from Baseline WPAI at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

Other Outcomes (8)

• Muscle strength

  Change from Baseline muscle strength at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

• Handgrip strength

  Change from Baseline handgrip strength at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

• 6-minute walk test (6-MWT)

  Change from Baseline 6-MWT at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.

Study Arms (2)

Personalized multimodal treatment

EXPERIMENTAL

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

Other: Intervention group

Standard care

ACTIVE COMPARATOR

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

Other: Intervention group

Interventions

Intervention group 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).

Personalized multimodal treatment; Standard care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Universitair ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37759324 DERIVED

MeSH Terms

Conditions

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

Study Officials

• Elisabeth De Waele, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: February 24, 2022
• Study Start: April 24, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BE (1)