NCT01994655

Brief Summary

Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

7.1 years

First QC Date

November 20, 2013

Last Update Submit

November 20, 2013

Conditions

Hot Flashes

Keywords

climacteric symptomsmenopausenurses

Outcome Measures

Primary Outcomes (1)

  • KMI

    KMI is the short of Kupperman Index,which is a questionnaire to assesses the severity of climacteric symptoms.

    up to 2 years

Secondary Outcomes (1)

  • blood lipid

    up to 2 years

Study Arms (1)

Doing exercise

EXPERIMENTAL

We want to use Kupperman Index to assess the severity of climacteric symptoms,and assess the effect of doing exercise fof the climacteric symptoms

Other: Doing exercise

Interventions

Doing exerciseOTHER

We want to investigate the effects of exercise on climacteric symptoms

Also known as: Exercise
Doing exercise

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Women aged 40-55 who has climacteric symptoms

You may not qualify if:

  • \- Women who have serious climacteric symptoms and other diseases which could interrupt the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hot Flashes

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Peking University

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

August 1, 2008

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

November 26, 2013

Record last verified: 2013-11