Condition category
Not Applicable
Date applied
07/01/2002
Date assigned
07/01/2002
Last edited
07/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Hiroko Sugiura

ORCID ID

Contact details

Nursing Course
School of Medicine
Gifu University
1-1 Yanagido
Gifu
501-1193
Japan
+81 (0)58 293 3232
hirokos@cc.gifu-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Grant no.'s: 08780091 and 07772270

Study information

Scientific title

Acronym

Study hypothesis

The design of the study was mostly on the basis of encouraging middle-aged women to increase their moderate exercise and consequently make those who have less activity aware of their serum lipids status.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

None of the subjects who participated in the 2-year trial had any specific disease.

Intervention

All exercise group were asked to use the same type of pedometer and record their daily steps for a period of two years. The control and exercise groups were asked to keep the same food intake as they had before. It should be mentioned that the food intake and types of meals in most Japanese middle-aged women have the same pattern. The recorded daily steps and serum lipid factors were analysed at the following times: initial, 6, 15 and 24 months after the moderate exercise started. The data obtained for the control and exercise groups were then compared and conclusions and recommendations were given.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1999

Overall trial end date

01/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Two groups of subjects were considered for this study: 14 subjects as the exercise group and 13 as the control group. They were selected from eligible volunteers on the basis of 40-60 year old women. The subjects of this study were randomly selected from the inhabitants of a community. None of the subjects who participated in the 2-year trial had any specific disease.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

27

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1999

Recruitment end date

01/01/2001

Locations

Countries of recruitment

Japan

Trial participating centre

Nursing Course
Gifu
501-1193
Japan

Sponsor information

Organisation

Ministry of Education, Culture, Sports, Science and Technology (Japan)

Sponsor details

Japan 2-5-1 Marunouchi Chiyoda-ku
Tokyo
100-8959
Japan

Sponsor type

Government

Website

http://www.mext.go.jp/english/

Funders

Funder type

Government

Funder name

Ministry of Education, Science, Sports and Culture of Japan (Japan) - Grant-in-Aid for Scientific Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11846892

Publication citations

  1. Results

    Sugiura H, Sugiura H, Kajima K, Mirbod SM, Iwata H, Matsuoka T, Effects of long-term moderate exercise and increase in number of daily steps on serum lipids in women: randomised controlled trial [ISRCTN21921919]., BMC Womens Health, 2002, 2, 1, 3.

Additional files

Editorial Notes