Spinal Cord InjuriesNCT03392155
Performance and Nutrition Program for Athletes in Adaptive Sports
A study testing Training & Nutrition in people with Spinal Cord Injuries and Physical Disability, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Physical Disability
- What is being tested?
- Training & Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- All groups:
- Any documented or reported health condition that would be contraindicated to a progressive exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effectiveness of a 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.
- Conditions
- Spinal Cord Injuries, Physical Disability
- Being tested
- Training & Nutrition
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training & NutritionBehavioural
Exercise at moderate to high intensities and diet education/counseling
| Study group | Role | What they receive |
|---|---|---|
| Training & Nutrition | Experimental | Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks. Receives: Behavioral: Training & Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The World Health Organization Quality of Life Score (WHOQOL-BREF)
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.
Measured: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Secondary outcomes (3)
Change in exercise self-efficacy score (for participants not living with spinal cord injury)
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.
Measured: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Change in exercise self-efficacy score (for participants living with spinal cord injury)
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.
Measured: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Change in self-reported un-weighed food records
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.
Measured: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start9 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meegan G. Van Straaten, Mayo Clinic
- Investigators
- Meegan G Van Straaten, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392155
- Sponsor's protocol ID
- 17-005392
- Status last verified
- Jun 2019
- First submitted
- 26 Dec 2017
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Performance and Nutrition Program for Athletes in Adaptive Sports
- ClinicalTrials.gov ID
- NCT03392155
- Acronym / sponsor ID
- 17-005392
- Conditions
- Spinal Cord Injuries, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training & Nutrition | Experimental | Behavioral: Training & NutritionParticipants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants with traumatic or non-traumatic spinal cord injury
- Able to perform progressive exercise program
- Willingness to participate in study
- Functional upper extremity range of motion
- Able to perform progressive exercise program
Key exclusion criteria (2 listed)
- Any documented or reported health condition that would be contraindicated to a progressive exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training & NutritionExercise at moderate to high intensities and diet education/counseling | Behavioural | Training & Nutrition |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meegan G Van Straaten principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training & Nutrition in people with Spinal Cord Injuries and Physical Disability, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.