- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07815366
Effectiveness of Eccentric Cycling Exercise in Ambulatory Rehabilitation for Patients With Cardiopulmonary Diseases: A Pragmatic Randomized Controlled Trial
In eccentric cycling exercise (ECC), the cyclist must oppose backwards moving pedals on a specialized motor-driven ergometer. Throughout this process, the force applied on the pedals exceeds the torque generated by the lengthening muscle (negative work), concurrently generating and storing elastic recoil energy . During ECC the cyclist is able to reach fourfold higher forces compared to conventional concentric cycling exercise (CON). At identical work-rates however, ECC is associated with a lower cardiac output 5 and requires up to 80% less oxygen uptake than CON. Hence, ECC is described as a promising and efficient exercise method with low metabolic costs. ECC exhibits greater effectiveness compared to CON, especially in terms of increasing muscle strength, muscle hypertrophy, six-minute walk distance (6MWD).
Acute studies during cycle ergometries have proven that ECC is effective to provide exercise at beneficial levels with low metabolic demand, even at low intensities in patients with chronic cardiopulmonary conditions, such as pulmonary hypertension or COPD.
However, whether these benefits can be achieved in a real world setting such as an ambulatory rehabilitation is unknown. Therefore, the rational of the study is to evaluate the effectiveness of ECC vs. standard training in healthy individuals during a three-month time period.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In eccentric cycling exercise (ECC), the cyclist must oppose backwards moving pedals on a specialized motor-driven ergometer. Throughout this process, the force applied on the pedals exceeds the torque generated by the lengthening muscle (negative work), concurrently generating and storing elastic recoil energy. During ECC the cyclist is able to reach fourfold higher forces compared to conventional concentric cycling exercise (CON) . At identical work-rates however, ECC is associated with a lower cardiac output 5 and requires up to 80% less oxygen uptake 6 than CON. Hence, ECC is described as a promising and efficient exercise method with low metabolic costs. Some studies suggests that ECC may exhibit greater effectiveness compared to CON, especially in terms of increasing muscle strength, muscle hypertrophy, six-minute walk distance (6MWD).
A loss in muscle mass and sarcopenia is present also in the non-diseased population and is increasing with age. A yearly loss of muscle mass in the general population is around 1% at the age of 40 and increases to 2% at the age of 70. This loss in muscle mass can be accelerated in patients with chronic cardiopulmonary diseases and especially in patients with lung cancer undergoing systemic therapies, mainly as chemotherapy.
A recent systematic review with meta-analysis, including studies with a total of 867 patients with lung cancer, conclusively demonstrated that patients undergoing chemotherapy are at risk for a marked loss of skeletal muscle mass and sarcopenia.14 Another study found in around 50% of their lung cancer patients receiving chemotherapy a significant reduction in muscle cross sectional area.15 Sarcopenia has a high burden of disease and has been found to be associated with significant lower survival in patients, as well as with a range of negative outcomes including disability, frailty, morbidity, and reduced quality of life. To prevent sarcopenia patients with cardiopulmonary disease, and patients undergoing chemotherapy should perform regular exercise training. Supervised exercise training and three months of rehabilitation have been shown to be effective, safe and well-tolerated in patients with chronic cardiopulmonary or pulmonary vascular disease. Therefore, a three-month ambulatory rehabilitation program provides a reliable option for these patients to exercise regularly in a supervised setting.
However, patients with advanced cardiopulmonary diseases, such as chronic obstructive pulmonary disease, heart failure, pulmonary hypertension, interstitial lung disease, or advanced stage lung cancer, often suffer from exercise intolerance. In patients whose cardiopulmonary limitations are so severe that they cannot even reach beneficial exercise intensities, the value of an ambulatory rehabilitation program needs to be carefully considered.
Nevertheless, with the features of ECC, even these patients are able to exercise at beneficial levels while maintaining a low metabolic demand. Previous studies have shown that ECC can be effective, even at low intensities, in patients with chronic cardiopulmonary conditions such as pulmonary hypertension or chronic obstructive pulmonary disease. Interestingly, patients additionally reported less perceived dyspnea with unchanged leg fatigue. Furthermore, ECC was associated with reduced pulmonary arterial pressure and improved right ventricular function.
However, whether these benefits can be achieved in a real world setting such as an ambulatory rehabilitation is unknown. Therefore, the rational of the study is to evaluate the effectiveness of ECC on healthy individuals during a three-month training period.
To study potential underlying physiology and effects of ECC in higher exercise intensities, we will also include an exploratory healthy control group that will train similarly as patients with cardiopulmonary disease on the ECC during three month.
This trial investigates the healthy control group.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Svizzera, 8091
- Universitätsspital Zürich
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Healthy participants without known Cardiopulmonary disease.
- Provided written informed consent
- Wiling to voluntarily exercise for 3 month on the eccentric ergometer without a specific indication for rehabilitation
Exclusion Criteria:
- Inability to follow the exercise procedure.
- Vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage) will not be included into the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Eccentric cycling
Eccentric cycling for three month
|
Participants exercise for three month on an eccentric ergometer
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Peak work rate
Lasso di tempo: Pre and post the three month exercise persiod
|
Peak work rate will be measured using standardized cardiopulmonary exercise testing on a cycling ergometer.
|
Pre and post the three month exercise persiod
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Peak oxygen uptake
Lasso di tempo: Pre and post the three month exercise period.
|
Peak oxygen uptake will be measured using standardized cardiopulmonary exercise testing on a cycling ergometer.
The participant is connected with a metabolic unit via mouth peace.
Oxygen uptake will be measured breath by breath.
|
Pre and post the three month exercise period.
|
|
Patient reported perceived dyspnea at peak exercise
Lasso di tempo: Pre and post three month exercise period
|
Patient reported perceived dyspnea at peak exercise will be measured using the Borg 10 item scale during standardized cardiopulmonary exercise testing on a cycling ergometer.
At peak exercise the participant will be ask on a scale from 1 to 10 how he would rate the dyspnea
|
Pre and post three month exercise period
|
|
Patient reported perceived leg fatigue
Lasso di tempo: Pre and post three month exercise period.
|
Patient reported perceived leg fatigue at peak exercise will be measured using the Borg 10 item scale during standardized cardiopulmonary exercise testing on a cycling ergometer.
At peak exercise the participant will be ask on a scale from 1 to 10 how he would rate the leg fatigue.
|
Pre and post three month exercise period.
|
|
Peak quadriceps extension force
Lasso di tempo: Pre and post three month exercise period.
|
The peak force that the quadriceps can produce during knee extension is measured on a isokinet.
|
Pre and post three month exercise period.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AmbEcc Healthy
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .