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Completed

NCT Number: NCT03392155

Performance and Nutrition Program for Athletes in Adaptive Sports

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Physical Disability Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training & Nutrition

Behavioral

Exercise at moderate to high intensities and diet education/counseling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Effectiveness of a Performance and Nutrition Program for Athletes in Adaptive Sports

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 5, 2018
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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