Performance and Nutrition Program for Athletes in Adaptive Sports
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|ClinicalTrials.gov Identifier: NCT03392155|
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Physical Disability||Behavioral: Training & Nutrition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Meegan G Van Straaten||Mayo Clinic|