Undersøgelse af optimale FES-træningsegenskaber efter rygmarvsskade
The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short [HI-SHORT] and low-long [LO-LONG]. Both groups (n=10 per group) will exercise on the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). [HI-SHORT] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. [LO-LONG] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for [HI-SHORT] and [LO-LONG] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Canton of Lucerne
-
Nottwil, Canton of Lucerne, Schweiz, 6207
- Swiss Paraplegic Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Greater than 6-weeks post-trauma after SCI.
- Traumatic and atraumatic spinal cord injuries between C7 and T10
- Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B.
- Age between 18-75 years old.
- Both male and female.
- Have at least 90º bilateral knee flexion.
- Able to perform FES muscle contractions (not FES intolerant).
- Able to follow verbal instructions.
Exclusion Criteria:
- A recent history of trauma to the lower limb.
- Severe or infected pressure sore on weight-bearing skin areas.
- Illness caused by acute urinary tract infection.
- Uncontrolled spasticity or pain.
- History of cardiovascular / cardiorespiratory disease contraindicating exercise.
- Uncontrolled orthostatic hypotension.
- Unhealed decubiti at electrode placement area.
- Recurrent and uncontrolled autonomic dysreflexia.
- Active heterotopic ossification.
- Other peripheral or central neurologic injury.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: [HI-SHORT]
High-intensity interval training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 10 x 2-min exercise intervals with 1-2 min of recovery between intervals. High intensity is achieved by high FES current amplitude (120-150 milliampere, patient dependent) |
One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals. |
|
Aktiv komparator: [LO-LONG]
Low-moderate intensity continuous training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 20+ min continuous exercise. Lower intensity is achieved by lower FES current amplitude (< 90-100 milliampere, patient dependent) |
Both interventions are different modalities of FES-evoked leg exercise, three-four times per week for 6-8 weeks (24 therapy sessions). The comparator intervention ([LO-LONG]) uses 20-40 min (patient state of fitness dependent) of continuous leg exercise of lower intensity. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Aerobic Fitness
Tidsramme: Day 0 to 6 weeks
|
Change of Peak Oxygen Uptake - VO2peak (L/min) |
Day 0 to 6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle Near Infrared Spectroscopy
Tidsramme: Day 0 to 6 Weeks
|
Change of resting muscle arterial oxygen saturation (%) |
Day 0 to 6 Weeks
|
|
Strength Fitness
Tidsramme: Day 0 to 6 weeks
|
Change of Peak Power Output (Watts) |
Day 0 to 6 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle Volume
Tidsramme: Day 0 to 6 weeks
|
Changes of muscle volume (L) |
Day 0 to 6 weeks
|
|
Muscle Fatigue
Tidsramme: Day 0 to 6 weeks
|
Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value |
Day 0 to 6 weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Glen M Davis, Prof. Dr., University of Sydney
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-11
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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