- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03709095
Sprint Interval Training During Rehabilitation After Spinal Cord Injury (SprintSCI)
15 oktober 2018 uppdaterad av: McMaster University
Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting.
The current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week.
Given the move towards shortened length of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of therapy time.
Sprint interval training (SIT) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to MICT.
However, there are no controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing inpatient rehabilitation.
The primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25 minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient clinical rehabilitation.
It was hypothesized that five weeks of SIT and MICT would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment.
It was also hypothesized that SIT would be well tolerated and elicit higher levels of cardiovascular strain than MICT.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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Hamilton, Ontario, Kanada, L8S 4L8
- McMaster University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Participants with sub-acute spinal cord injury (time since injury: 14 - 182 days)
- Undergoing inpatient rehabilitation
- Aged 18-65 years
- Injury level at the second cervical vertebrae (C2) or below
Exclusion Criteria:
- Unable to perform arm-ergometry training
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Moderate Intensity Continuous Training
Training was performed three times a week for five weeks.
Each session began with a 2 minute warm up, and concluded with a 3 minute cool down.
Following the warm-up, participants performed 20 minutes of arm cycling at a self-selected cadence at 45-65% of their peak power output.
Total training duration was 25 mins.
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Participants utilized the arm ergometer for improving aerobic exercise capacity
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Experimentell: Sprint Interval Training
The SIT protocol was adopted from Gillen and colleagues (See Ref), and consisted of 3 x 20 second "all-out" efforts at ≥ 100% of an individuals peak power output.
Each sprint was interspersed by 120 seconds of active recovery at 10% of an individuals peak power output.
Total training duration was 10 mins.
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Participants utilized the arm ergometer for improving aerobic exercise capacity
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in peak power output
Tidsram: Change in peak power output from baseline to 5 weeks
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maximum amount of power produced during a graded exercise test on the arm-ergometer
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Change in peak power output from baseline to 5 weeks
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Change in sub-maximal arm-ergometry
Tidsram: Change in sub-maximal arm-ergometry from baseline to 5 weeks
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Participants performed three 5-minute steady state workloads on the arm-ergometer at power outputs corresponding to RPE's of 8, 10 and 12. Participants were given a minimum of 2 minutes, and a maximum of 5 minutes of rest in between each workload.
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Change in sub-maximal arm-ergometry from baseline to 5 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cardiovascular Responses
Tidsram: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Monitored heart rate throughout each training session
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Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Perceptual Responses
Tidsram: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Monitored ratings of perceived exertion throughout each training session
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Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Change in self-efficacy for exercise
Tidsram: Change in self-efficacy from baseline to 5 weeks
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Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.
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Change in self-efficacy from baseline to 5 weeks
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Exercise Satisfaction
Tidsram: Measured only at the end of the intervention (5 weeks)
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Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.
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Measured only at the end of the intervention (5 weeks)
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Pain perceptions
Tidsram: Measured only at the end of the intervention (5 weeks)
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Through a questionnaire, participants rated how much shoulder pain, bodily pain, and physical discomfort they typically experience throughout the day and how much pain they experienced with the intervention they were allocated to.
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Measured only at the end of the intervention (5 weeks)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Audrey L Hicks, PhD, McMaster University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.
- Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.
- Gillen JB, Martin BJ, MacInnis MJ, Skelly LE, Tarnopolsky MA, Gibala MJ. Twelve Weeks of Sprint Interval Training Improves Indices of Cardiometabolic Health Similar to Traditional Endurance Training despite a Five-Fold Lower Exercise Volume and Time Commitment. PLoS One. 2016 Apr 26;11(4):e0154075. doi: 10.1371/journal.pone.0154075. eCollection 2016.
- Astorino TA, Thum JS. Within-session responses to high-intensity interval training in spinal cord injury. Disabil Rehabil. 2018 Feb;40(4):444-449. doi: 10.1080/09638288.2016.1260648. Epub 2016 Dec 8.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2017
Primärt slutförande (Faktisk)
1 juni 2018
Avslutad studie (Faktisk)
1 juni 2018
Studieregistreringsdatum
Först inskickad
11 oktober 2018
Först inskickad som uppfyllde QC-kriterierna
15 oktober 2018
Första postat (Faktisk)
17 oktober 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SprintSCI
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