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| ID | Type | Description | Link |
|---|---|---|---|
| SNCTP000006132 | Other Identifier | Swiss National Clinical Trials Portal |
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The goal of this clinical trial is to assess the effects of eccentric arm-crank (KREHA) training compared to standard clinical routine strength (STAN) training in individuals undergoing primary spinal cord injury (SCI) rehabilitation.
The main questions this trail aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eccentric arm-crank (KREHA) training | Experimental | The eccentric training intervention consists of 20 training sessions performed on a symmetric arm-crank (Krafttraining mittels exzentrischer Handkurbel, KREHA) device. The training sessions have a duration of approximately 30 min and will be completed within twelve weeks, with a maximum of three sessions per week. |
|
| Standard clinical routine strength (STAN) training | Active Comparator | The standard strength training intervention consists of a total of 20 training sessions at the gym of the study center, performed following clinical routine procedures. The training sessions have a duration of approximately 60 min and will be completed within twelve weeks, with around three sessions per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eccentric (KREHA) training | Procedure | 20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper body strength | Change in upper body strength will be measured by a one-repetition maximum (1RM) bench press (in kg). The maximum amount of weight that can be pushed upwards for one repetition, while lying in a supine position on a weight training bench. | < 1 week pre and 12 weeks post intervention start. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper body strength | Change in upper body strength measured by a 1RM bench pull (in kg). The maximum amount of weight that can be pulled upwards for one repetition, while lying in a prone position on a weight training bench. | < 1 week pre and 12 weeks post intervention start. |
| Handgrip strength |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the KREHA training (total number of training sessions) | Successful implementation of the KREHA training in the clinical routine, by assessing whether the 20 KREHA sessions are completed within 12 weeks. | Throughout the intervention phase, week 0-12 |
| Feasibility of the KREHA training progression (number of sessions adapted) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anneke Hertig-Godeschalk, PhD | Contact | +414 9396603 | anneke.hertig@paraplegie.ch | |
| Fabian Ammann, MSc | Contact | +41419396624 | fabian.ammann@paraplegie.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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Matched-pair randomized controlled trial
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| Standard clinical routine strength (STAN) training | Procedure | The regular strength training intervention consists of a total of 20 training sessions at the gym of the study center, performed following clinical routine procedures. |
|
Change in maximum strength of three handgrip measurements (in kg) of both hands using a Jamar Handgrip Dynamometer. |
| < 1 week pre and 12 weeks post intervention start. |
| Aerobic performance | Change in cardiopulmonary adaptations, measured by aerobic performance in an exercise test on a regular arm-crank ergometer. A ramp protocol starting at 20 Watt followed by 1 Watt / 6 sec increments to failure will be used. The following parameters will be evaluated during this aerobic endurance test: power at failure at the end of the test (in Watt), peak oxygen uptake during the test (in ml/kg/min), maximal heart rate (bpm) | < 1 week pre and 12 weeks post intervention start. |
| Muscle volume | Magnetic resonance imaging (MRI) of relevant upper body muscles of the dominant upper arm and shoulder will be used to measure change in muscle volume. | < 1 week pre and 12 weeks post intervention start. |
| Arm circumference | Change in arm circumference of the right and left lower and upper arm (in cm), will be used to estimate muscle volume. | < 1 week pre and 12 weeks post intervention start. |
| Functioning during activities of daily living | Change in functioning during activities of daily living will be assessed by the Spinal Cord Independence Measure (SCIM) as extracted from clinical records. The SCIM total score ranges from 0-100, with higher scores indicating higher levels of functional independence. | < 1 week pre and 12 weeks post intervention start. |
| Health-related quality of life | Change in health-related quality of life will be assessed using the Short Form Health Survey (SF-12). Weighted physical and mental component scores range from 0-100, with higher scores indicating better physical or mental health. | < 1 week pre and 12 weeks post intervention start. |
Feasibility of the KREHA training progression, by assessing how many training sessions needed to be adapted. |
| Throughout the intervention phase, week 0-12 |
| Feasibility of the KREHA training progression (power adaptation) | Feasibility of the KREHA training progression, by assessing how much the target power (in Watts) of a training session needed to be adapted compared to the initially planned progression. | Throughout the intervention phase, week 0-12 |
| 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 |
| D014947 | Wounds and Injuries |
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