NCT06895850

Brief Summary

We performed a longitudinal crossover clinical study on survivors of COVID-19. We compared a standard rehabilitation protocol using elastic bands versus a novel eccentric cycling training protocol in individuals who have been discharged after being hospitalized due to COVID-19. We assessed the effects of these two rehabilitation modalities on physical performance, quality of life, and cognitive function parameters. We found that both protocols induced significant improvements in all variables. However, eccentric cycling induced such improvements involving less time per session. These findings could significantly impact strategies to treat COVID-19 survivors, which is a novel and impactful contribution to the body of knowledge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 20, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

rehabilitationhospitalizationeccentric cycling

Outcome Measures

Primary Outcomes (5)

  • Muscle Strength (Medical Research Council; MRC)

    Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) was evaluated bilaterally following the MRC scale guidelines \[17\]. Each muscle group was rated on a scale from 0 (paralysis) to 5 (normal strength). The MRC-sum score evaluates global muscle strength. The final score ranges from 0 (total paralysis) to 60 (normal muscle strength in all four limbs) \[17\].

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Handgrip Strength

    Manual handgrip strength was evaluated with a hand dynamometer (Jamar, USA) with the participant, seated with the elbow at 90°, performing a maximum grip for 3 seconds, expressed in kilograms. Three attempts were made for the dominant upper limb, with a one-minute rest between attempts, and the highest of the three values was registered \[18\].

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Six-Minute Walk Test (6MWT)

    The 6MWT measured the distance a person could walk in 6 minutes as quickly as possible \[10\]. It was conducted in a 30 m long corridor. If the participant experienced chest pain, dyspnoea, sweating, cyanosis, or chest discomfort during the test, the test was stopped, and the distance covered until the onset of symptoms was recorded.

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • One-Minute Sit-to-Stand Test

    The participants were asked to cross their arms with hands on the opposite shoulders and to sit and stand from the chair as many times as possible in one minute \[19\]. This test serves as an estimate of lower extremity power and functional capacity \[19\].

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Timed up and go (TUG)

    Participants were instructed to rise from a chair, walk three meters, turn around a cone, walk back to the chair, and sit down with their back leaning against the backrest as quickly and safely as possible \[10\]. The time in seconds (s) needed to perform the entire sequence was recorded. Each participant performed the TUG in three attempts with a 2-minute rest between attempts, and the fastest time was used for further analyses.

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

Secondary Outcomes (5)

  • Body Composition

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Peak Expiratory Flow

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Post-COVID-19 Functional Status Scale (PCFS)

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Montreal Cognitive Assessment (MoCA)

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

  • Barthel Index

    Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants performed the eccentric cycling training for 8 weeks (experimental group)

Other: Eccentric cycling training

Standard Rehabilitation

ACTIVE COMPARATOR

The training protocol for STD REHAB consisted of the same 5 min warm-up protocol used in ECC, followed by three sets of 8 repetitions of bicep curls, triceps extensions, shoulder abduction, bodyweight squats, deadlifts, and leg abductions with an elastic band with 2 min inter-set rest. The resistance of the elastic band tension was progressively increased according to the participant's tolerance based on RPE. ECC training was programmed for \~20-30 min, while STD REHAB lasted \~60 min per session.

Other: Standar Rehabilitation

Interventions

The training protocol for the ECC consisted of a 5-minute warm-up on a stationary ergometer (RS1 Go, Life fitness, USA) before completion of the prescribed workout. In the first two weeks, participants completed two sets of 10 minutes of eccentric cycling at an RPE between 9-11 with 2 minutes of inter-set rest. Then, during weeks 3-8, participants completed two sets of 15 min of eccentric cycling at an RPE between 13-15 with 2 min inter-set rest.

Intervention

The training protocol for STD REHAB consisted of the same 5 min warm-up protocol used in ECC, followed by three sets of 8 repetitions of bicep curls, triceps extensions, shoulder abduction, bodyweight squats, deadlifts, and leg abductions with an elastic band with 2 min inter-set rest. The resistance of the elastic band tension was progressively increased according to the participant's tolerance based on RPE. ECC training was programmed for \~20-30 min, while STD REHAB lasted \~60 min per session.

Standard Rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were hospital-discharged at least 6 months before the start of the study and had not undergone rehabilitation after hospital discharge.

You may not qualify if:

  • Patients who did not pass the medical check-up before the study (patients with myocarditis and/or abnormal troponins or electrocardiograms from the last three months), oxygen-dependent patients, those with musculoskeletal injuries, bedridden patients, disoriented patients, or those with severe mental disabilities were excluded due to being unsafe to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Andres Bello

Santiago, Santiago Metropolitan, 8370146, Chile

Location

Related Publications (1)

  • Inostroza M, Valdes O, Tapia G, Nunez O, Kompen MJ, Nosaka K, Penailillo L. Effects of eccentric vs concentric cycling training on patients with moderate COPD. Eur J Appl Physiol. 2022 Feb;122(2):489-502. doi: 10.1007/s00421-021-04850-x. Epub 2021 Nov 20.

    PMID: 34799753BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study utilized a two-treatment crossover design. Each treatment was eight weeks in duration, with a two-week washout period. The order of treatments was randomized and counterbalanced.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Exercise and Rehabilitation Science Lab

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

October 30, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations