UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025954
Receipt number R000029841
Scientific Title The effect of stretch pole exercise on the respiratory function in elderly people
Date of disclosure of the study information 2017/02/01
Last modified on 2022/08/07 18:22:05

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Basic information

Public title

The effect of stretch pole exercise on the respiratory function in elderly people

Acronym

The effect of stretch pole exercise on the respiratory function in elderly people

Scientific Title

The effect of stretch pole exercise on the respiratory function in elderly people

Scientific Title:Acronym

The effect of stretch pole exercise on the respiratory function in elderly people

Region

Japan


Condition

Condition

elderly people

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the change of the respiratory function after stretch pole exercise in elderly people.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Chest Expansion
Vital capacity
Forced expiratory volume in 1 second
Inspiratory muscle strength

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Patients receive regular rehabilitation in the first 10 days.
Late 10 days stretch pole exercise is also added.

Interventions/Control_2

Patients receive regular rehabilitation and stretch pole exercise in the first 10 days.
Late 10 days they receive only regular rehabilitation.

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Hospitalized patients

Key exclusion criteria

Patients with spinal cord diseases
Patients with respiratory diseases
Patients with dementia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Suzuki

Organization

Tokyo metropolitan police hospital

Division name

Department of rehabilitation

Zip code

164-8541

Address

4-22-1 NAKANO, NAKANO-KU, TOKYO

TEL

09079884391

Email

shinzi05230523@yahoo.co.jp


Public contact

Name of contact person

1st name Shinji
Middle name
Last name Suzuki

Organization

Tokyo metropolitan police hospital

Division name

Department of rehabilitation

Zip code

164-8541

Address

4-22-1 NAKANO, NAKANO-KU, TOKYO

TEL

09079884391

Homepage URL


Email

shinzi05230523@yahoo.co.jp


Sponsor or person

Institute

Tokyo metropolitan police hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo metropolitan police hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo metropolitan police hospital

Address

toukyouto nakanoku nakano 4-22-1

Tel

03-5343-5611

Email

shinzi05230523@yahoo.co.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 02 Month 01 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 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

Enrolling by invitation

Date of protocol fixation

2016 Year 12 Month 14 Day

Date of IRB

2016 Year 12 Month 14 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2017 Year 05 Month 23 Day

Date of closure to data entry

2017 Year 05 Month 23 Day

Date trial data considered complete

2017 Year 05 Month 23 Day

Date analysis concluded

2017 Year 05 Month 23 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 01 Day

Last modified on

2022 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029841


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name