Performance and Nutrition Program for Athletes in Adaptive Sports

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Physical Disability
• Interventions: Behavioral: Training & Nutrition

• Registration Number: NCT03392155
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Study Start: 2018-01-09
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training & Nutrition	Training & Nutrition	Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in The World Health Organization Quality of Life Score (WHOQOL-BREF)	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

Name	Time	Method
Change in exercise self-efficacy score (for participants living with spinal cord injury)	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	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.
Change in exercise self-efficacy score (for participants not living with spinal cord injury)	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States