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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 RehaStimâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [HI-SHORT] | Experimental | 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) |
|
| [LO-LONG] | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [LO-LONG] | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic Fitness | Change of Peak Oxygen Uptake - VO2peak (L/min) | Day 0 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Near Infrared Spectroscopy | Change of resting muscle arterial oxygen saturation (%) | Day 0 to 6 Weeks |
| Strength Fitness | Change of Peak Power Output (Watts) |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Volume | Changes of muscle volume (L) | Day 0 to 6 weeks |
| Muscle Fatigue | Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ines Bersch, PhD | Contact | +41 41 939 42 06 | ines.bersch@paraplegie.ch | |
| Kathrin Schafer, MPH | Contact | +41 41 939 43 34 | kathrin.schafer@paraplegie.ch |
| Name | Affiliation | Role |
|---|---|---|
| Glen M Davis, Prof. Dr. | University of Sydney | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Recruiting | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Randomised Controlled Design
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|
| [HI-SHORT | Other | One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals. |
|
| Day 0 to 6 weeks |
| Day 0 to 6 weeks |
| D014947 | Wounds and Injuries |