UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029868
Receipt No. R000033799
Scientific Title The effect of hip flexor muscles on hip joint extension angle during the late stance phase in walking
Date of disclosure of the study information 2017/11/07
Last modified on 2020/05/10 (Ver. 4)

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Basic information
Public title The effect of hip flexor muscles on hip joint extension angle during the late stance phase in walking
Acronym The effect of hip flexor muscles on hip joint extension angle during the late stance phase in walking
Scientific Title The effect of hip flexor muscles on hip joint extension angle during the late stance phase in walking
Scientific Title:Acronym The effect of hip flexor muscles on hip joint extension angle during the late stance phase in walking
Region
Japan

Condition
Condition healthy adult and elderly persons
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is as follows;
1.To measure the kinematic and kinetic parameters of hip joint and ankle joint during the late stance phase of walking in healthy adults and clarify the relationship between them.
2.To clarify the relationship between the maximum dynamic extension angle and the maximum passive extension angle of the hip joint in the late stance phase of walking
3.To investigate whether the reduction of hip flexion muscle strength causes a decrease in the maximal dynamic extension angle of the hip joint in the late stance of walking, or whether the increase in this muscular strength increases its extension angle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This study is an intervention study that performs muscle strengthening training of the hip flexor muscles for 6 weeks.
The primary outcome is the maximum dynamic extension angle of the hip joint in the late stance phase of walking.
The evaluation items are the kinematic and kinetic parameters of hip joint and ankle joint in the late stance phase of walking.
The evaluation is made before and after intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Contents of the intervention are as follows;
1.Intervention period: 6 weeks
2.Exercise style: muscle strengthening training of hip flexor muscles.
3.Exercise method:
1 set: in standing posture, flexion of hip joint in 3 seconds (concentric contraction) , hold posture after flexion for 2 seconds (isometric contraction) , slowly return to the original posture in 3 seconds (eccentric contraction)
4.Number of exercises: 3 sets at a time. 2 minutes break between sets.
5.Exercise intensity: Three kinds of sera bands with different tension are used. Every two weeks to strengthen the load from a weak tension sera band to a strong sera band.
6.Frequency of exercise: Three times a week.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Selection criteria are as follows;
1.the age is an adult (including elderly), 2.the participants are willing to cooperate as a volunteer, 3.the participants are agreeing to participate in research is there.
Key exclusion criteria Exclusion criteria are as follows;
1. Persons who have the history of operation for lower limb exercise disease in the past
2. Persons who have the physical exercising pain that interferes with research on lower back pain and lower extremity joint pain
3. Persons whose appearance abnormal attitude and abnormal walking are remarkable
4. Persons who has the disease that can't tolerate exercise at the time of intervention (muscle strengthening training) and before and after intervention (various measurements, walking)
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Ryuichi
Middle name
Last name Sayra
Organization Osaka Medical College
Division name Department of Rehabilitation Medicine, Division of Comprehensive Medicine, Faculty of Medicine
Zip code 569-8686
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email saura@osaka-med.ac.jp

Public contact
Name of contact person
1st name Hisatomo
Middle name
Last name Sato
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email reh041@osaka.med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Medical University Research Ethics Committee
Address Daigaku-machi, Takatsuki, Osaka, Japan
Tel 072-683-1221
Email rinri@osaka-med.ac.jp

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
2017 Year 11 Month 07 Day

Related information
URL releasing protocol https://doi.org/10.1016/j.jos.2019.09.014
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1016/j.jos.2019.09.014
Number of participants that the trial has enrolled 40
Results 
 Hip flexion strength increased from 1.68 to 1.95 Nm/kg and 1.04 to 1.21 Nm/kg in the healthy and the locomotive syndrome groups, respectively. The walking ability was increased in both groups. Consequently, the two-step test score improved from 1.17 to 1.30 and the stage of locomotive syndrome improved improved in 9 participants.
Results date posted
2020 Year 05 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The healthy group had an age of 46.7 (14.9)years, a height of 163.4 (10.5) cm, a weight of 62.3 (11.0) kg, and a BMI of 23.3 (2.9).
The locomotive syndrome group had an age of 71.0 (11.4) years, a height of 154.2 (5.9) cm, a weight of 58.3 (7.7) kg, and a BMI of 24.5 (2.2). (mean(standard deviation))
Participant flow 
 A Two-step test score of 1.3 was established as the cutoff for locomotive syndrome(LS), 1.3 or more was considered to indicate being healthy, and less than 1.3 was considered to indicate LS. The healthy group was 24 and the locomotive syndrome group was 16. Participants performed hip flexor muscle training (intervention) for 6 weeks, but there were 2 dropouts in each group. Finally, 22 healthy groups and 14 LS groups were used for data analysis.
Adverse events 
One participant stopped training due to lower back pain and two were excluded because they were hospitalized. In addition, one participant was excluded due to a lack of data.
Outcome measures 
The main outcome are hip flexor muscles strength and the secondary outcome are walking ability and a stage of locomotive syndrome. The hip flexor muscles strength of the healthy group and the locomotive syndrome group was significantly improved (p <0.0001, p = 0.0031, respectively). Walking ability (left and right step length, stride length, walking speed) was significantly improved in both groups and a stage of locomotive syndrome was improved in the locomotive syndrome group (p = 0,041).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 10 Month 16 Day
Date of IRB
2017 Year 10 Month 10 Day
Anticipated trial start date
2017 Year 11 Month 07 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 07 Day
Last modified on
2020 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033799