UMIN-CTR Clinical Trial

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

healthy adult and elderly persons

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka Medical College

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

07

Day

URL releasing protocol

https://doi.org/10.1016/j.jos.2019.09.014

Publication of results

Published

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

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 related information

Registered date

2017

Year

11

Month

07

Day

Last modified on

2020

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033799