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Covid19CISCO-21NCT04900961

CISCO-21 Prevent and Treat Long COVID-19.

A study testing Resistance Exercise in people with Covid19, run by NHS Greater Glasgow and Clyde at 2 sites 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

Many people have long-lasting symptoms after COVID-19, such as breathlessness, fatigue and chest pain. So far, research studies of treatments for COVID-19 have focused on the life-threatening acute illness; few studies look at treatments to improve long-term health after COVID-19. Read more about this study

Who is it for?
Any age
Conditions the study is for
Covid19
What is being tested?
Resistance Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
2 sitesUnited Kingdom
Study dates
1 Jun 2021to 21 Feb 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Virology PCR positive laboratory diagnosis and/or point of care test positive for COVID-and/or
  • Positive Lateral Flow Test (confirmation from notes or by participant) and/or
  • Positive COVID antibody test
  • Persistent symptoms for at least 4 weeks from symptoms onset (Groups A \& B only)
  • Presentation type - one of group A, B or C.

Who cannot join

  • Physiotherapy as part of standard care e.g. post intensive care unit (ICU), post high dependency unit (HDU),
  • No expectation of being able to walk within 3 months
  • Unable to provide informed consent,
  • Unable to comply with the protocol.
  • Known pregnancy

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Queen Elizabeth University Hospital

    Glasgow

  • Royal Infirmary

    Glasgow

Other trials in United Kingdom

About this study

Official title: Prevention and Early Treatment of the Long-term Physical Effects of Coronarvirus-19 (COVID-19): a Randomised Clinical Trial of Resistance Exercise.

Many people have long-lasting symptoms after COVID-19, such as breathlessness, fatigue and chest pain. So far, research studies of treatments for COVID-19 have focused on the life-threatening acute illness; few studies look at treatments to improve long-term health after COVID-19. COVID-19, particularly when this requires a hospital admission, can lead to weight loss and muscle wasting, contributing to worse outcomes. Muscle strengthening (resistance-based) exercise could improve outcomes in the long-term.

Read the detailed description

The rationale for our study has two main parts. The first (primary) addresses a gap in therapy, notably, for a non-pharmacological intervention. To address this gap, the investigators have set out to develop a lifestyle intervention that may be helpful to patients with persisting symptoms in the recovery (or convalescence) phase after COVID-19. Specifically, the investigators will train participants to undertake a pragmatic resistance-based exercise intervention that they can learn and apply according to their circumstances in-hospital or in the community. The rationale is predicated on providing patients with a personalised therapy option and empowering them in the self-management of their recovery following illness due to COVID-19 infection.

The second area of need is the general lack of evidence-based medicines for patients who have persisting symptoms after COVID-19. To address this gap, there is a need for rapid trials to evaluate multiple therapeutic candidates to urgently provide doctors (and their patients) with clinical evidence to inform treatment decisions. To address this gap, the investigatorsaim to create a platform for rapid trials of new treatments after COVID-19. The investigators wish to seize the opportunity afforded by this trial to set-up a transferable framework for future trials in COVID-19. The rationale is to provide a low-cost trials resource to facilitate the rapid set-up and cost-efficient delivery of multiple other trials. This will be a parallel work strand during the trial. The investigators will develop a Working Group of stakeholders from across the National Health Service (NHS) and Universities in Scotland and our COVID-19 patient and public invovlement (PPI) group (which includes co-applicants and collaborators). Key considerations include repurposing novel therapy, potential for efficacy, safety, endpoint, sample size, feasibility interim analyses, power, the Medicines and Healthcare products Regulatory Agency (MHRA) and costs. As part of the plan of work in application (Aim 3), the researchers and PPI Group will scope these potential interventions within the context of a platform trial with a view to identifying candidates to follow-on after the exercise intervention trial. This will cut the costs of doing future trials and allow more patients the opportunity to contribute to medical research that will improve outcomes for people recovering from COVID-19.

Our team is multidisciplinary, multi-ethnic, gender-balanced and drawn from across NHS Scotland, and the University of Glasgow. The investigators are leading the CISCO-19 study (ClinicalTrials.gov Identifier: NCT04403607), funded by the Chief Scientist Office (CSO), in the West of Scotland, using medical imaging of the hearts, lungs, and kidneys of patients, to understand the impact of COVID-19. The investigators have consulted with members of the public, including people with COVID-19, in designing this study.

The investigators will also undertake exploratory research into the vascular biology of COVID-19 infection. This work will be undertaken in collaboration with scientists in the University of Glasgow, including the British Heart Foundation Centre for Research Excellence and the Medical Research Council (MRC) Centre for Virus Research. A blood sample at 3 months will be collected and stored in the NHS Biorepository.

In order to assess the natural history, longer-term follow-up for health outcomes will be undertaken using electronic record linkage to patient records omitting the need for participants to undergo further research visits after the end of the trial. If after initial analysis longer term, follow up via national records is felt to be worthwhile additional funding will be sought for this.

Alignment with other national / international initiatives Our proposal will link with other prioritised studies in the United Kingdom. In general, co-enrolment would be desirable to synergise the studies. Our study will bring in new resource to enhance enrolment into existing studies, specifically, by engaging more sites, and more research staff.

Conditions
Covid19
Being tested
Resistance Exercise
Keywords
COVID-19, Clinical trial, Graded resistance exercise, Personalised medicine, Post-COVID-19 syndrome, Long COVID
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

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

  • Resistance ExerciseOther

    The exercise regimens are generic and designed not to require expert physiotherapy input, therefore, the availability of NHS physiotherapists, which may be at times limited, will not be a barrier to implementation

Study groups in NCT04900961
Study groupRoleWhat they receive
InterventionActive comparatorA personalised, resistance-based exercise intervention for patients during the convalescence phase in-hospital through to 3-months post-discharge, a duration reflecting chronic, maintenance treatment studies. To maximise enrolment of eligible patients, the intervention may be initiated in-hospital or in the community post-discharge. Resistance bands may be used according to the exercise guideline.
Receives: Other: Resistance Exercise
ControlNo interventionStandard of care treatment

What is being measured

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

  1. Incremental Shuttle Walk Test

    This is a validated measure of functional capacity, with test-retest reliability and evidence of being responsive to rehabilitation interventions.

    Measured: at 3 months

Secondary outcomes (12)
  1. Spirometry

    The basic spirometry measurement will be forced vital capacity (FVC).

    Measured: at 3 months

  2. Handgrip Strength

    Handgrip strength will be recorded using a handheld dynamometer. For handgrip strength, measurements are performed until 3 measurements are within 5% of each other. Typically, 3 - 6 manoeuvres in each hand are performed. Responses in the dominant hand will be recorded.

    Measured: at 3 months

  3. Short Physical Performance Battery

    The Short Physical Performance Battery (SPPB) is a series of brief, simple physical tests including of the ability to stand for 10 seconds with the feet in 3 different positions (together side-by-side (score 0 - 1), semi-tandem (score 0 - 1), and tandem (score 0 - 2)), two timed trials of a 3m or 4m walk (fastest recorded) and the time to rise from a chair 5 times. The score ranges from 0 to 12 (higher scores reflect better extremity function). The gait and chair subtests score from 0 to 4.

    Measured: at 3 months

  4. EuroQol-5 dimension (EQ)-5D

    EuroQol-5 dimension (EQ)-5D, a patient reported outcome measure.

    Measured: at 3 months

  5. Patient Health Questionnaire-4 (PHQ4)

    Patient Health Questionnaire-4 (PHQ4), a patient reported outcome measure.

    Measured: at 3 months

  6. Brief Illness Perception Questionnaire (IPQ)

    Brief Illness Perception Questionnaire (IPQ), a patient reported outcome measure.

    Measured: at 3 months

  7. Duke Activity Status Index (DASI)

    Duke Activity Status Index (DASI), a patient reported outcome measure.

    Measured: at 3 months

  8. International Physical Activity Questionnaires Short Form (IPAQ-SF)

    International Physical Activity Questionnaires Short Form (IPAQ-SF), a patient reported outcome measure.

    Measured: at 3 months

  9. Fatigue questionnaire

    Fatigue questionnaire, a patient reported outcome measure.

    Measured: at 3 months

  10. Fried Frailty phenotype

    Weight loss; exhaustion; grip strength; low physical activity; and slow walking pace

    Measured: 3 months

  11. Episodes of care

    Episodes of healthcare care (primary, secondary, physiotherapy, rehabilitation)

    Measured: at 3 months

  12. Hospitalisation

    Hospitalisation for any reason, representing a serious adverse event

    Measured: at 3 months

Timeline

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

  1. First posted25 May 2021
  2. Study start1 Jun 2021
  3. Primary completion30 Aug 2024
  4. Study completion21 Feb 2025

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900961
Sponsor's protocol ID
GN20CA537
Acronym
CISCO-21
Status last verified
Feb 2025
First submitted
10 May 2021
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The Investigator may share individual participant data (IPD) with bone fide researchers, subject to Sponsor approval.

Publications

  • Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.

    PubMed 32352535
  • Mangion K, Morrow A, Bagot C, Bayes H, Blyth KG, Church C, Corcoran D, Delles C, Gillespie L, Grieve D, Ho A, Kean S, Lang NN, Lennie V, Lowe DJ, Kellman P, Macfarlane PW, McConnachie A, Roditi G, Sykes R, Touyz RM, Sattar N, Wereski R, Wright S, Berry C. The Chief Scientist Office Cardiovascular and Pulmonary Imaging in SARS Coronavirus disease-19 (CISCO-19) study. Cardiovasc Res. 2020 Dec 1;116(14):2185-2196. doi: 10.1093/cvr/cvaa209.

    PubMed 32702087
  • Ho FK, Celis-Morales CA, Gray SR, Katikireddi SV, Niedzwiedz CL, Hastie C, Ferguson LD, Berry C, Mackay DF, Gill JM, Pell JP, Sattar N, Welsh P. Modifiable and non-modifiable risk factors for COVID-19, and comparison to risk factors for influenza and pneumonia: results from a UK Biobank prospective cohort study. BMJ Open. 2020 Nov 19;10(11):e040402. doi: 10.1136/bmjopen-2020-040402.

    PubMed 33444201
  • Briscoe M, Sykes R, Krystofiak T, Peck O, Mangion K, Berry C. Clinical significance of coronavirus disease 2019 in hospitalized patients with myocardial injury. Clin Cardiol. 2021 Mar;44(3):332-339. doi: 10.1002/clc.23530. Epub 2021 Jan 27.

    PubMed 33501708
  • Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.

    PubMed 26797036
  • Houchen-Wolloff L, Daynes E, Watt A, Chaplin E, Gardiner N, Singh S. Which functional outcome measures can we use as a surrogate for exercise capacity during remote cardiopulmonary rehabilitation assessments? A rapid narrative review. ERJ Open Res. 2020 Dec 7;6(4):00526-2020. doi: 10.1183/23120541.00526-2020. eCollection 2020 Oct.

    PubMed 33313302
  • Al Ozairi E, Alsaeed D, Taliping D, Jalali M, El Samad A, Mashankar A, Taghadom E, Guess N, Gill JMR, Sattar N, Gray C, Welsh P, Gray SR. Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength. Trials. 2020 Jun 22;21(1):557. doi: 10.1186/s13063-020-04480-2.

    PubMed 32571396
  • Berry C, McKinley G, Bayes HK, Anderson D, Lang CC, Gill A, Morrow A, Sykes R, Taggart D, Kamdar A, Welsh P, Dawkes S, McConnachie A, Gray SR. Resistance Exercise Therapy After COVID-19 Infection: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2534304. doi: 10.1001/jamanetworkopen.2025.34304.

    PubMed 41213124
  • Morrow A, Gray SR, Bayes HK, Sykes R, McGarry E, Anderson D, Boiskin D, Burke C, Cleland JGF, Goodyear C, Ibbotson T, Lang CC, McConnachie, Mair F, Mangion K, Patel M, Sattar N, Taggart D, Taylor R, Dawkes S, Berry C. Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise-CISCO-21. Trials. 2022 Aug 15;23(1):660. doi: 10.1186/s13063-022-06632-y.

    PubMed 35971155

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Exercise in people with Covid19, run by NHS Greater Glasgow and Clyde at 2 sites 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 5 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Incremental Shuttle Walk Test (time frame: at 3 months). 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 NCT04900961, which also lists 9 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 25 Feb 2025.

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