- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07652398
Effects of Passive Recovery Methods After High-Intensity Cycling Exercise (RECOVER-CYCLE)
Acute Effects of Five Passive Recovery Interventions Following High-Intensity Cycling Exercise: A Randomized Five-Period Crossover Trial
Přehled studie
Postavení
Detailní popis
This study is designed as a randomized, five-period, five-treatment crossover trial. All participants will complete a standardized high-intensity cycling exercise protocol once weekly for five consecutive weeks. Following each cycling session, participants will receive one passive recovery intervention. The five recovery interventions are compression therapy, vacuum therapy, kinesiology taping, passive rest, and classical massage.
Participants will be randomized to one of five intervention sequences to balance the order of recovery interventions across the study period. Each intervention will be administered once to each participant, and all participants will receive all five interventions. A seven-day interval between weekly exercise sessions will separate intervention periods. The crossover design allows each participant to serve as his or her own control when comparing the acute effects of the recovery interventions.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Healthy adult volunteers aged 18-35 years
- Able to perform high-intensity cycling exercise
- No musculoskeletal injury within the last six months
- No known cardiovascular, neurological, or metabolic disease
- Not using medication that may affect exercise performance, pain perception, or recovery
- Willing to attend all five study sessions
- Willing to receive all five passive recovery interventions
- Provided written informed consent
Exclusion Criteria:
- Presence of acute or chronic musculoskeletal injury
- History of cardiovascular, neurological, respiratory, or metabolic disease
- Contraindication to high-intensity exercise
- Contraindication to compression therapy, vacuum therapy, kinesiology taping, passive rest, or classical massage
- Skin allergy, open wound, dermatological disease, or sensitivity to kinesiology tape
- Use of analgesic, anti-inflammatory, muscle relaxant, or performance-enhancing medication during the study period
- Participation in another exercise or recovery intervention study during the study period
- Failure to attend all study sessions or comply with study procedures
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Sequence A: Compression-Vacuum-KT-Rest-Massage
Participants randomized to Sequence A will complete a standardized high-intensity cycling exercise session once weekly for five consecutive weeks.
Immediately after each session, they will receive recovery interventions in the following order: Week 1 compression therapy, Week 2 vacuum therapy, Week 3 kinesiology taping, Week 4 passive rest, and Week 5 classical massage.
|
All participants will perform a standardized supervised high-intensity cycling exercise protocol once weekly for five consecutive weeks.
The cycling protocol will be administered before the assigned recovery intervention in each study period.
Exercise intensity, duration, and progression will be standardized across participants and sessions.
Compression therapy will be administered using the Doctor Life MK400L 6-chamber sequential intermittent compression device, code MK4L250-BL.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, and device settings.
Ostatní jména:
Vacuum therapy will be administered using the Intelect Neo Therapy System with the Chattanooga Intelect Neo Vacuum Module.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, vacuum cup placement, and vacuum pressure settings.
Ostatní jména:
Kinesiology taping will be applied immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
Tape placement, application technique, tension, target region, and wear time will be standardized across participants.
Participants will rest quietly after the standardized high-intensity cycling exercise session for a standardized duration.
No manual therapy, mechanical therapy, taping, or additional recovery intervention will be administered during the passive rest condition.
Classical massage will be administered immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
The treated body region, massage techniques, sequence of techniques, pressure, and application duration will be standardized across participants.
|
|
Experimentální: Sequence B: Vacuum-KT-Rest-Massage-Compression
Participants randomized to Sequence B will complete a standardized high-intensity cycling exercise session once weekly for five consecutive weeks.
Immediately after each session, they will receive recovery interventions in the following order: Week 1 vacuum therapy, Week 2 kinesiology taping, Week 3 passive rest, Week 4 classical massage, and Week 5 compression therapy.
|
All participants will perform a standardized supervised high-intensity cycling exercise protocol once weekly for five consecutive weeks.
The cycling protocol will be administered before the assigned recovery intervention in each study period.
Exercise intensity, duration, and progression will be standardized across participants and sessions.
Compression therapy will be administered using the Doctor Life MK400L 6-chamber sequential intermittent compression device, code MK4L250-BL.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, and device settings.
Ostatní jména:
Vacuum therapy will be administered using the Intelect Neo Therapy System with the Chattanooga Intelect Neo Vacuum Module.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, vacuum cup placement, and vacuum pressure settings.
Ostatní jména:
Kinesiology taping will be applied immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
Tape placement, application technique, tension, target region, and wear time will be standardized across participants.
Participants will rest quietly after the standardized high-intensity cycling exercise session for a standardized duration.
No manual therapy, mechanical therapy, taping, or additional recovery intervention will be administered during the passive rest condition.
Classical massage will be administered immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
The treated body region, massage techniques, sequence of techniques, pressure, and application duration will be standardized across participants.
|
|
Experimentální: Sequence C: KT-Rest-Massage-Compression-Vacuum
Participants randomized to Sequence C will complete a standardized high-intensity cycling exercise session once weekly for five consecutive weeks.
Immediately after each session, they will receive recovery interventions in the following order: Week 1 kinesiology taping, Week 2 passive rest, Week 3 classical massage, Week 4 compression therapy, and Week 5 vacuum therapy.
|
All participants will perform a standardized supervised high-intensity cycling exercise protocol once weekly for five consecutive weeks.
The cycling protocol will be administered before the assigned recovery intervention in each study period.
Exercise intensity, duration, and progression will be standardized across participants and sessions.
Compression therapy will be administered using the Doctor Life MK400L 6-chamber sequential intermittent compression device, code MK4L250-BL.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, and device settings.
Ostatní jména:
Vacuum therapy will be administered using the Intelect Neo Therapy System with the Chattanooga Intelect Neo Vacuum Module.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, vacuum cup placement, and vacuum pressure settings.
Ostatní jména:
Kinesiology taping will be applied immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
Tape placement, application technique, tension, target region, and wear time will be standardized across participants.
Participants will rest quietly after the standardized high-intensity cycling exercise session for a standardized duration.
No manual therapy, mechanical therapy, taping, or additional recovery intervention will be administered during the passive rest condition.
Classical massage will be administered immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
The treated body region, massage techniques, sequence of techniques, pressure, and application duration will be standardized across participants.
|
|
Experimentální: Sequence D: Rest-Massage-Compression-Vacuum-KT
Participants randomized to Sequence D will complete a standardized high-intensity cycling exercise session once weekly for five consecutive weeks.
Immediately after each session, they will receive recovery interventions in the following order: Week 1 passive rest, Week 2 classical massage, Week 3 compression therapy, Week 4 vacuum therapy, and Week 5 kinesiology taping.
|
All participants will perform a standardized supervised high-intensity cycling exercise protocol once weekly for five consecutive weeks.
The cycling protocol will be administered before the assigned recovery intervention in each study period.
Exercise intensity, duration, and progression will be standardized across participants and sessions.
Compression therapy will be administered using the Doctor Life MK400L 6-chamber sequential intermittent compression device, code MK4L250-BL.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, and device settings.
Ostatní jména:
Vacuum therapy will be administered using the Intelect Neo Therapy System with the Chattanooga Intelect Neo Vacuum Module.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, vacuum cup placement, and vacuum pressure settings.
Ostatní jména:
Kinesiology taping will be applied immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
Tape placement, application technique, tension, target region, and wear time will be standardized across participants.
Participants will rest quietly after the standardized high-intensity cycling exercise session for a standardized duration.
No manual therapy, mechanical therapy, taping, or additional recovery intervention will be administered during the passive rest condition.
Classical massage will be administered immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
The treated body region, massage techniques, sequence of techniques, pressure, and application duration will be standardized across participants.
|
|
Experimentální: Sequence E: Massage-Compression-Vacuum-KT-Rest
Participants randomized to Sequence E will complete a standardized high-intensity cycling exercise session once weekly for five consecutive weeks.
Immediately after each session, they will receive recovery interventions in the following order: Week 1 classical massage, Week 2 compression therapy, Week 3 vacuum therapy, Week 4 kinesiology taping, and Week 5 passive rest.
|
All participants will perform a standardized supervised high-intensity cycling exercise protocol once weekly for five consecutive weeks.
The cycling protocol will be administered before the assigned recovery intervention in each study period.
Exercise intensity, duration, and progression will be standardized across participants and sessions.
Compression therapy will be administered using the Doctor Life MK400L 6-chamber sequential intermittent compression device, code MK4L250-BL.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, and device settings.
Ostatní jména:
Vacuum therapy will be administered using the Intelect Neo Therapy System with the Chattanooga Intelect Neo Vacuum Module.
The intervention will be applied immediately after the standardized high-intensity cycling exercise session.
The application will be delivered according to a standardized protocol, including participant positioning, treated body region, application duration, vacuum cup placement, and vacuum pressure settings.
Ostatní jména:
Kinesiology taping will be applied immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
Tape placement, application technique, tension, target region, and wear time will be standardized across participants.
Participants will rest quietly after the standardized high-intensity cycling exercise session for a standardized duration.
No manual therapy, mechanical therapy, taping, or additional recovery intervention will be administered during the passive rest condition.
Classical massage will be administered immediately after the standardized high-intensity cycling exercise session by a trained physiotherapist.
The treated body region, massage techniques, sequence of techniques, pressure, and application duration will be standardized across participants.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Total Quality Recovery (TQR) Score
Časové okno: Baseline, immediately after recovery intervention, and 24 hours after exercise
|
Recovery status assessed using the Total Quality Recovery (TQR) scale following each recovery intervention.
|
Baseline, immediately after recovery intervention, and 24 hours after exercise
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Perceived Recovery Status
Časové okno: Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
Perceived recovery will be assessed using a standardized perceived recovery scale after each passive recovery intervention.
|
Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
|
Rating of Perceived Exertion (RPE)
Časové okno: Immediately after exercise
|
Perceived exertion will be assessed using the Rating of Perceived Exertion scale during or after the standardized cycling exercise protocol.
|
Immediately after exercise
|
|
Muscle Soreness Visual Analog Scale (VAS)
Časové okno: Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
Perceived muscle soreness will be assessed using a Visual Analog Scale following each recovery intervention.
|
Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
|
Vertical Jump Performance
Časové okno: Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
Lower-limb explosive performance will be assessed using a vertical jump test.
|
Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
|
Sit-and-Reach Test
Časové okno: Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
Hamstring and lower-back flexibility will be assessed using the sit-and-reach test.
|
Baseline, immediately after the recovery intervention, and 24 hours after exercise
|
|
Heart Rate
Časové okno: Baseline, immediately after exercise, immediately after the recovery intervention, and 24 hours after exercise
|
Heart rate will be measured to monitor physiological response to exercise and recovery interventions.
|
Baseline, immediately after exercise, immediately after the recovery intervention, and 24 hours after exercise
|
|
Blood Pressure
Časové okno: Baseline, immediately after exercise, immediately after the recovery intervention, and 24 hours after exercise
|
Systolic and diastolic blood pressure will be measured to monitor cardiovascular response to exercise and recovery interventions.
|
Baseline, immediately after exercise, immediately after the recovery intervention, and 24 hours after exercise
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E-60116787-020-734897
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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