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Trial record 9 of 26 for:    Spinal Cord Injuries | ( Map: Minnesota, United States )
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Performance and Nutrition Program for Athletes in Adaptive Sports

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392155
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Meegan G. Van Straaten, Mayo Clinic

Study Description
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Brief Summary:
Researchers are trying to evaluate and recommend sustainable and effective health and wellness programs for people with spinal cord injury (SCI) and other physical disabilities.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Physical Disability Behavioral: Training & Nutrition Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effectiveness of a Performance and Nutrition Program for Athletes in Adaptive Sports
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Training & Nutrition
Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks.
 Behavioral: Training & Nutrition
Exercise at moderate to high intensities and diet education/counseling


Outcome Measures
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Primary Outcome Measures :
  1. Change in The World Health Organization Quality of Life Score (WHOQOL-BREF) [ Time Frame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28) ]
    The World Health Organization (WHOQOL-BREF) is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life.


Secondary Outcome Measures :
  1. Change in exercise self-efficacy score (for participants not living with spinal cord injury) [ Time Frame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28) ]
    The Barriers Specific Self-Efficacy Scale is a self-reported survey and was designed to measure subjects' perceived capabilities to exercise even if faced with barriers to exercise. Scores can range from zero to 100 with higher numbers indicating better confidence that the subject has the capability to exercise.

  2. Change in exercise self-efficacy score (for participants living with spinal cord injury) [ Time Frame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28) ]
    The Spinal Cord Injury Exercise Self-Efficacy Scale (ESES) is a self-reported survey and includes 10 questions and a maximum score of 40 with higher scores indicating more confidence to exercise.

  3. Change in self-reported un-weighed food records [ Time Frame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28) ]
    Self-reported un-weighed food records are collected by participant interview with a registered dietician and also with digital photography of full food plates and left-overs. Improvement in dietary intake is indicated from a "yes" or "no" of whether study participants have met individual goals that are determined during baseline session with dietician.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group1 (Group with spinal cord injury):

  • Participants with traumatic or non-traumatic spinal cord injury
  • Able to perform progressive exercise program
  • Willingness to participate in study

Group 2 (Able-bodied group):

  • Functional upper extremity range of motion
  • Able to perform progressive exercise program
  • Willingness to participate in study

Group3 (Other physical disability group):

  • Participants with a physical disability other than spinal cord injury
  • Able to perform progressive exercise program
  • Willingness to participate in study

Exclusion Criteria:

All groups:

• Any documented or reported health condition that would be contraindicated to a progressive exercise program

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392155


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Meegan G Van Straaten Mayo Clinic
More Information
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Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

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Responsible Party: Meegan G. Van Straaten, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03392155    
Other Study ID Numbers: 17-005392
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries