CISCO-21 Prevent and Treat Long COVID-19.

NCT04900961 | Completed DMC

• 1 other identifier: GN20CA537
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Covid19

Keywords

COVID-19; Clinical trial; Graded resistance exercise; Personalised medicine; Post-COVID-19 syndrome; Long COVID

Outcome Measures

Primary Outcomes (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.

  at 3 months

Secondary Outcomes (12)

• Spirometry

  at 3 months

• Handgrip Strength

  at 3 months

• Short Physical Performance Battery

  at 3 months

• EuroQol-5 dimension (EQ)-5D

  at 3 months

• Patient Health Questionnaire-4 (PHQ4)

  at 3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

A 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.

Other: Resistance Exercise

Control

NO INTERVENTION

Standard of care treatment

Interventions

Resistance Exercise OTHER

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

Intervention

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (2)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Royal Infirmary

Glasgow, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 32352535 BACKGROUND

• 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.

  PMID: 32702087 BACKGROUND

• 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.

  PMID: 33444201 BACKGROUND

• 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.

  PMID: 33501708 BACKGROUND

• 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.

  PMID: 26797036 BACKGROUND

• 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.

  PMID: 33313302 BACKGROUND

• 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.

  PMID: 32571396 BACKGROUND

• 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.

  PMID: 41213124 DERIVED

• 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.

  PMID: 35971155 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Resistance Training

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Colin Berry, BSc MBChB PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 25, 2021
• Study Start: June 1, 2021
• Primary Completion: August 30, 2024
• Study Completion: February 21, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

GB (2)