UMIN-CTR Clinical Trial

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
Institute	Tokyo metropolitan police hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029841