COVID-19UNLOCKNCT05254301
Nutrition and LOComotoric Rehabilitation in Long COVID-19
A study testing Intervention group in people with COVID-19, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Apr 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Intervention group
- Keywords
- Nutrition, Pilot Study, Physical Therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Personalized multimodal treatment | Experimental | A combination of biometric parameter oriented nutritional counseling and a tailored physical training program. Receives: 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.) Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks
Secondary outcomes (5)
Multi-dimensional Fatigue Inventor (MFI-20)
The MFI is a self-report instrument designed to measure fatigue and was initially developed in Dutch17 for patients with cancer. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. It consists of 20 items divided over 5 dimensions (each 4 items) and is scored on a 5-point Likert scale. The higher the score the more severe the fatigue and by consequence the more impact fatigue has on daily functioning.
Measured: 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)
Health-related Quality of Life will be measured by the EQ-5D-5L. This questionnaire comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels from no problems tot extreme problems. Next it contains a self-rated health status on a vertical visual analogue scale where the endpoints are labelled the best health you can imagine' and 'the worst health you can imagine'. This test has proven valuable for assessing physical health-related QoL (25).
Measured: 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)
Functional status will be evaluated for changes using the PCFS, specifically developed for COVID patients by Klok and colleagues.
Measured: 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)
Mental status will be evaluated for differences using HADS.This test is a simple tool to assess both anxiety and depression, each with 7 questions.
Measured: 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)
Work capability will also be assessed using the Work Productivity and Activity Impairment. With 6 questions it asks about the decline in productivity and activity in the past 7 days. There are 3 versions available but all evaluate on absence, presence, loss of productivity and decline of activities during work. The WPAI is considered the best validated questionnaire for determining health-related work productivity and has been validated in various chronic inflammatory diseases.
Measured: Change from Baseline WPAI at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start24 Apr 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Elisabeth De Waele, Universitair Ziekenhuis Brussel
- Investigators
- Elisabeth De Waele, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254301
- Sponsor's protocol ID
- 2022-EDW-01
- Other IDs
- LCOV21-1306
- Acronym
- UNLOCK
- Status last verified
- May 2024
- First submitted
- 19 Feb 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jimenez Garcia BG, Roggeman S, Leemans L, Cools W, Beckwee D, De Waele E. Increased physical performance after personalised physiotherapy and nutritional counselling in adults with post-COVID-19 condition: a feasibility randomised trial. Commun Med (Lond). 2026 Mar 3;6(1):215. doi: 10.1038/s43856-026-01486-w.
PubMed 41775918Roggeman 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.
PubMed 37759324
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05254301
- Acronym / sponsor ID
- UNLOCK / 2022-EDW-01
- Conditions
- COVID-19
- Keywords
- Nutrition, Pilot Study, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 24 Apr 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized multimodal treatment | Experimental | Other: Intervention groupA combination of biometric parameter oriented nutritional counseling and a tailored physical training program. |
| Standard care | Active comparator | Other: Intervention groupPhysiotherapy with standard care advice for gradual cardiorespiratory and resistance training. (In this standard care setting, nutritional screening nor counseling is included.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThis 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). | Other | Personalized multimodal treatment, Standard care |
Primary outcome
1-minute sit-to-stand (1-MSTS)
Time frame: Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks
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)
5 secondary outcomes
Multi-dimensional Fatigue Inventor (MFI-20)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from Baseline WPAI at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41775918Jimenez Garcia BG, Roggeman S, Leemans L, Cools W, Beckwee D, De Waele E. Increased physical performance after personalised physiotherapy and nutritional counselling in adults with post-COVID-19 condition: a feasibility randomised trial. Commun Med (Lond). 2026 Mar 3;6(1):215. doi: 10.1038/s43856-026-01486-w.
- Derived from this study: PubMed 37759324Roggeman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth De Waele, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with COVID-19, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-minute sit-to-stand (1-MSTS) (time frame: Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254301, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.