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Long COVIDNCT05752331

Feasibility of Personalised Health Behaviour Coaching to Support Symptoms and Activities of Daily Living in Those With Long COVID-19.

A study testing Physical activity behavioural modification in people with Long COVID, run by Bournemouth University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot RCT aims to assess whether a simple PA behavioural modification intervention can be delivered safely and feasibly to individuals with Long COVID suffering long standing symptoms with concerns regarding their ability to perform activities of daily living. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID
What is being tested?
Physical activity behavioural modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited Kingdom
Study dates
1 Nov 2022to 15 Jun 2023
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

  • People who are aged 18 years or older
  • Have experienced at least one long COVID symptom for 12 weeks or longer
  • Additionally meet at least one of the following criteria: 1) positive SARS-CoV-2 PCR or antigen test (positive COVID-19 test) during the acute phase of illness; 2) positive SARS-CoV-2 antibody test at any time point; 3) symptoms consistent with SARS-CoV-2 (COVID-19) infection during the acute phase.

Who cannot join

  • Individuals who have previously been admitted to an intensive care unit (ICU) due to SARS-CoV-2
  • Receiving palliative or end-of-life care
  • Are actively participating in another research trial focused on long COVID

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Bournemouth University

    Bournemouth, Dorset, BH12 5BB

Other trials in United Kingdom

About this study

This pilot RCT aims to assess whether a simple PA behavioural modification intervention can be delivered safely and feasibly to individuals with Long COVID suffering long standing symptoms with concerns regarding their ability to perform activities of daily living.

Participants will be randomised to receive an 8-week physical activity behavioural modification intervention alongside usual care or usual care alone. The primary outcome for this study is to assess the safety and feasibility of the intervention, including recruitment targets, randomisation, completion rates and acceptability to the study.

Read the detailed description

Coronavirus (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), infecting over 254 million people worldwide to date. While the majority of positive cases have uncomplicated recoveries, some have prolonged periods of persistent symptoms, referred to as Long Covid (symptoms ≥12 weeks). Many of the typical symptoms observed in those with Long Covid (fatigue, shortness of breath \& cognitive dysfunction) are compounded by deconditioning associated with a sedentary lifestyle. This has become a major concern due to enforced lockdowns impacting individuals' abilities to conduct activities of daily living (ADL), causing many to resort to sedentary lifestyles. Worryingly, a significant association between sedentary behaviour and mental wellbeing has been highlighted in those with Long Covid, negatively impacting both physical and psychological symptoms.

Current research has focused on the lived experiences of people with Long Covid and how they undertake ADL. Key barriers to ADL included an ever-increasing depletion of energy reserves during low intensity physical activity (PA), an inability to manage symptoms of fatigue and breathlessness, and high levels of anxiety associated with safely pursing the potential benefits of PA. What's promising is that after expressing these barriers many individuals wished to prioritise recovery and return to a greater level of ADL as it provided a sense of normalisation and boosted overall mood. Subsequently, future research needs to investigate potential interventions which positively impact upon the sedentary behaviour of those with Long Covid and increase their ability to conduct ADL. Importantly, interventions of this nature must focus on reducing the symptoms of Long Covid during PA in order to promote a sense of safety while individuals purse the benefits of PA.

Therefore, this pilot randomised control trial (RCT) aims to assess whether a simple PA behavioural modification intervention can be delivered safely and feasibly to individuals with Long Covid who haven't been hospitalised due to Covid-19.

This pilot RCT will constitute a two parallel group study, with individuals randomised 1:1 to either an 8-week PA behavioural modification intervention alongside usual care (intervention group) or usual care alone (control group). Individuals with long standing symptoms (≥12 weeks) of COVID-19 who haven't previously been hospitalised will be recruited through university (staff \& students) and community based non-NHS groups in order to avoid lengthy NHS ethical approval during feasibility. Eligible participants will attend 2 visits to a BU laboratory at baseline (week 0) and study completion (week 9) to complete all physiological and psychological measures (detailed below).

The 8-week PA behavioural modification intervention will focus on engaging participants in ADL and lowering sedentary time. Each participant will receive one semi-structured motivational interview at baseline to discuss favourite activities and barriers and facilitators to PA. Participants will produce an individualised action plan following the interview that will be followed throughout the intervention to allow an individualised approach to take place. Participants will then be provided with a low-cost pedometer and PA diary to self-monitor and record daily PA. The PA diary will provide examples of various activities that can be done in and around the house, with an emphasis placed on simple, effective movements to reduce sedentary time. Following this, a researcher will conduct weekly virtual meetings with the participant to discuss the past weeks PA levels and provide future individualised goals to promote ADL. All participants will be notified of the government 'your Covid recovery' programme (usual care) which provides details and support on managing long term symptoms of Covid-19.

Conditions
Long COVID
Being tested
Physical activity behavioural modification
Keywords
Physical activity, Fatigue, Breathlessness
Medical subject headings
Post-Acute COVID-19 Syndrome, Motor Activity, Fatigue, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity behavioural modificationBehavioural

    8-week intervention consisting motivational interview, individualised action plan and weekly consultations regarding activities of daily living and symptom management.

Study groups in NCT05752331
Study groupRoleWhat they receive
Physical activity behavioural modificationExperimentalThe 8-week PA behavioural modification intervention will focus on engaging participants in ADL and lowering sedentary time. Each participant will receive one semi-structured motivational interview at baseline to discuss favourite activities and barriers and facilitators to PA. Participants will produce an individualised action plan following the interview that will be followed throughout the intervention to allow an individualised approach to take place. Participants will then be provided with a low-cost pedometer and PA diary to self-monitor and record daily PA. The PA diary will provide examples of various activities that can be done in and around the house, with an emphasis placed on simple, effective movements to reduce sedentary time. Following this, a researcher will conduct weekly virtual meetings with the participant to discuss the past weeks PA levels and provide future individualised goals to promote ADL.
Receives: Behavioral: Physical activity behavioural modification
Usual CareNo interventionAll participants will be notified of the government 'your Covid recovery' programme (usual care) which provides details and support on managing long term symptoms of Covid-19.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant recruitment

    At least 40% of eligible participants recruited to the study

    Measured: 8 weeks

  2. Participant randomisation

    At least 80% of participants randomised following informed consent

    Measured: 8 weeks

  3. Participant completion

    At least 80% of randomised participants completing the intervention period and post assessment visit

    Measured: 8 weeks

  4. Participant acceptability

    Assessed through a project tailored questionnaire on completing of the study

    Measured: 8 weeks

Secondary outcomes (9)
  1. Objective physical activity

    Accelerometer steps/day, Movement intensity \& time spend in domains of activity.

    Measured: 8-weeks

  2. Exercise capacity

    Incremental shuttle walk test

    Measured: 8-weeks

  3. Muscular strength and endurance

    30-second sit to stand test and hand grip dynamometry

    Measured: 8-weeks

  4. Lung Function

    Spirometry measures of FEV1 and FVC

    Measured: 8-weeks

  5. Health related quality of life

    EQ-5D-5L

    Measured: 8-weeks

  6. Breathlessness

    COPD Assessment Test (CAT) and MRC dyspnea scale

    Measured: 8-weeks

  7. Fatigue

    Chalder fatigue scale

    Measured: 8 weeks

  8. Anxiety and Depression

    Hospital anxiety and depression scale

    Measured: 8-weeks

  9. Cognitive impairment

    MoCA

    Measured: 8-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start1 Nov 2022
  3. Primary completion31 May 2023
  4. Study completion15 Jun 2023

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752331
Sponsor's protocol ID
LCACORN
Status last verified
Aug 2023
First submitted
28 Feb 2023
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity behavioural modification in people with Long COVID, run by Bournemouth University at 1 site in United Kingdom.

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 3 inclusion and 3 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 4 Aug 2023. 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 United Kingdom. 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?

Participant recruitment (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Aug 2023.

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