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COVID 19ECC-4-COVIDNCT06895850

Eccentric Cycling Vs. Standard Rehabilitation for Post-ICU Recovery in COVID-19 Survivors

A study testing Eccentric cycling training and Standar Rehabilitation in people with COVID 19, run by Universidad Nacional Andres Bello at 1 site in Chile.

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

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID 19
What is being tested?
Eccentric cycling training and Standar Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChile
Study dates
30 Oct 2021to 30 Jul 2022
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

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Universidad Andres Bello

    Santiago, Santiago Metropolitan, 8370146

Other trials in Chile

About this study

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.

Read the detailed description

Twenty patients (9 men, 11 women) between the ages of 30 and 60 years who had been hospitalized for COVID-19 in an ICU volunteered for this study. Participants were hospital-discharged at least 6 months before the start of the study and had not undergone rehabilitation after hospital discharge.

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. Twenty participants were recruited and completed this study. This sample was deemed sufficient as an a-priori power analysis (G*Power 3.1.9, Germany) estimated that 18 patients were required to test the anticipated effect, considering a statistical power of 0.8 and alpha <0.05. This effect was estimated based on the 18.7% increase in the 6-minute walking test observed after 12 weeks of eccentric training [10]. Considering a 10% dropout, we recruited 20 participants for this study.

Condition order was randomly arranged as either ECC then STD REHAB (n=10) or STD REHAB then ECC (n=10) to account for a potential order effect of treatments. Both interventions lasted eight weeks, and assessments were performed before and after the interventions. As shown in Fig. 1A, during the ECC participant performed eccentric cycling using an arm-and-leg motorized cycle ergometer (Model ABJ-107-2, Medical Technology Co LTD, China) while during the STD REHAB condition participants performed functional rehabilitation using strengthening exercises with elastic bands (Fig. 1B). During the 2-week wash-out period, the participants refrained from training in preparation for their second intervention.

2.3 Interventions The exercise intensity was matched between conditions throughout the intervention period using the 6-20 point rating of perceived exertion (RPE; Borg´s Scale) [10]. For both groups, RPE progressively increased during the first two weeks from 9 (very light) to 11 (fairly light), and then over the next five weeks from 13 (somewhat hard) to 15 (hard). Additionally, heart rate (HR) and blood pressure (Omron Serie 5/7156, USA), and oxygen saturation (Heal Force A3, CHOICEMMED, China) were measured immediately after all training sessions to quantify the cardiovascular demands of training, which were averaged between training sessions.

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.

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.

Conditions
COVID 19
Being tested
Eccentric cycling training, Standar Rehabilitation
Keywords
rehabilitation, hospitalization, eccentric cycling
Medical subject headings
COVID-19

What participants receive

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

  • Eccentric cycling trainingOther

    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.

  • Standar RehabilitationOther

    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.

Study groups in NCT06895850
Study groupRoleWhat they receive
InterventionExperimentalParticipants performed the eccentric cycling training for 8 weeks (experimental group)
Receives: Other: Eccentric cycling training
Standard RehabilitationActive comparatorThe 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.
Receives: Other: Standar Rehabilitation

What is being measured

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

  1. 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].

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

  2. 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].

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

  3. 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.

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

  4. 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].

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

  5. 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.

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

Secondary outcomes (5)
  1. Body Composition

    Anthropometric measurements were taken between 8 and 10 am after an overnight fast, including weight (kg) and height (cm). Furthermore, multifrequency bioimpedanciometry (InBody 120, InBody Co., Ltd, Republic of Korea) was used to determine the whole-body fat and muscle mass percentage [15] before and after interventions.

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

  2. Peak Expiratory Flow

    Pulmonary function was assessed with a mini-Wright peak flow meter (Clement Clarke, Mini-Wright PFM, United Kingdom) by measuring the maximum expiratory flow maintained for 10 milliseconds, expressed in L/min. This test was performed with the participant seated with their knees and hips flexed at 90°. In this position, participants performed a maximum inspiration, placed the device's mouthpiece in their mouth and sealed it with their lips and their nose clipped, and then was asked to breathe out as forcefully and quickly as possible. This manoeuvre was repeated thrice with a 2 min rest between each attempt, and the highest value achieved was recorded [16].

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

  3. Post-COVID-19 Functional Status Scale (PCFS)

    The PCFS is a validated questionnaire to assess the functionality of COVID-19 survivors upon hospital discharge [20]. It consists of an interview with questions about daily living activities, instrumental activities, social activities, and lifestyle that the patient must rate from 0 (no limitations) to 4 (severe functional limitation).

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

  4. Montreal Cognitive Assessment (MoCA)

    The MoCA test assesses cognitive function and takes approximately 10 minutes [22]. The MoCA evaluates orientation, short-term memory, visuospatial and executive functioning, language skills, abstraction, animal naming, and attention aspects through a guided questionnaire. The total score is a maximum of 30 points, with an additional point added if the person has no schooling. Scores below 26 points indicate cognitive dysfunction [22].

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

  5. Barthel Index

    This instrument is widely used to assess a person's ability to perform basic activities of daily living, providing a quantitative estimate of the degree of dependence. Patients scored their capacity to perform ten activities encompassing personal hygiene, eating, and moving around the home. Each activity was scored from 0 to 5, with 0 being unable to do it and five being completely independent in performing the task. All items were summed, with scores of 0-20 classified as total dependence, 21-60 as severe dependence, 61-90 as moderate dependence, 91-99 as slight dependence, and 100 as completely independent [23].

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

Timeline

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

  1. First posted26 Mar 2025
  2. Study start30 Oct 2021
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

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
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06895850
Sponsor's protocol ID
1
Acronym
ECC-4-COVID
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34799753

Questions about this trial

What is this clinical trial studying?

A study testing Eccentric cycling training and Standar Rehabilitation in people with COVID 19, run by Universidad Nacional Andres Bello at 1 site in Chile.

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 1 inclusion and 1 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 26 Mar 2025. 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 Chile. 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?

Muscle Strength (Medical Research Council; MRC) (time frame: Baseline, Pre- intervention (Eccentric cycling and Standard rehabilitation groups) and 8 week after interventions (post- Eccentric cycling and Standard rehabilitation groups)). The study lists 5 primary outcomes in all. 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 NCT06895850, which also lists 1 linked publication.

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 26 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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