UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014899 |
|---|---|
| Receipt number | R000017330 |
| Scientific Title | Effect of lumbar spine manipulation on asymptomatic cyclist sprint performance and hip flexibility |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2014/08/20 02:17:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of lumbar spine manipulation on asymptomatic cyclist sprint performance and hip flexibility
Acronym
Spinal manipulation impact on cyclists
Scientific Title
Effect of lumbar spine manipulation on asymptomatic cyclist sprint performance and hip flexibility
Scientific Title:Acronym
Spinal manipulation impact on cyclists
Region
| North America |
Condition
Condition
Exercise performance
Classification by specialty
| Medicine in general | Neurology | Orthopedics |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Determine the impact of lumbar spine manipulation on cyclist sprint power and hip flexibility amongst asymptomatic cyclists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure the 0.5 km cycle ergometer sprint time, rating of perceived exertion, maximum exercise heart rate, and rating of perceived exertion.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
12 Participants received sham acupuncture
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) participant had a BMI under 30, between 18-55 years of age, completed informed consent, answered no to all PAR-Q items, reported regularly engaging in cycling exercise, and could complete the sprint test in under 100 seconds.
Key exclusion criteria
1) The participant had a cardiovascular, respiratory, neurologic, or muscular condition. They consumed caffeine 6 hours before the test. They were a student at a chiropractic or acupuncture college. They received acupuncture or spinal manipulation in the 2 previous weeks. They reported adverse events to acupuncture or spinal manipulation. They were on medications that would make exercise unsafe for them. They had pain they rated greater than a 3 on a 1-10 numeric rating scale.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eric Olson, BS |
Organization
Texas Chiropractic College
Division name
Research
Zip code
Address
5912 Spencer Highway, Pasadena, TX 77505
TEL
2819985704
jward@txchiro.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | John Ward |
Organization
Texas Chiropractic College
Division name
Research
Zip code
Address
5912 Spencer Highway, Pasadena, TX 77505
TEL
2819985704
Homepage URL
jward@txchiro.edu
Sponsor or person
Institute
NCMIC
Institute
Department
Personal name
Funding Source
Organization
NCMIC
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results: Lumbar spine manipulation did not demonstrate statistically significant between group changes in sit-and-reach (p=0.765), 0.5 km sprint performance time (p=0.877), maximum exercise heart rate (p-0.944), or RPE (p=0.875).
Conclusions: Preliminarily, lumbar spinal manipulation was not shown to impact cycle ergometer sprint performance or hip flexibility of asymptomatic cyclists.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
