UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016091
Receipt number R000018238
Scientific Title An open-label, multicenter, non-randomized single-arm comparative study of the rehabilitation effects on pulmonary function in the elderly kyphosis patients.
Date of disclosure of the study information 2015/01/01
Last modified on 2018/07/03 16:41:43

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

An open-label, multicenter, non-randomized single-arm comparative study of the rehabilitation effects on pulmonary function in the elderly kyphosis patients.

Acronym

A study of rehabilitation effects on lung function in the elderly kyphosis patients.

Scientific Title

An open-label, multicenter, non-randomized single-arm comparative study of the rehabilitation effects on pulmonary function in the elderly kyphosis patients.

Scientific Title:Acronym

A study of rehabilitation effects on lung function in the elderly kyphosis patients.

Region

Japan


Condition

Condition

Kyphosis

Classification by specialty

Pneumology Geriatrics Orthopedics
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study effects of rehabilitation on pulmonary function in the elderly kyphosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement of pulmonary function

Key secondary outcomes

Improvement of exercise tolerability
Improvement of ADL
Improvement of symptoms


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Patients receive rehabilitation treatments 3 times a week for 6 weeks. Rehabilitation treatments include:
1. Thorax ROM exercise and stretch (5 minutes)
2. Muscle training ( 5 times x 3 sets)
3. Aerobic exercise (20 minutes)

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



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Kyphosis patients with kyphosis index 15 or more.
2. Age 65 or older, male or female.
3. Written informed consent.

Key exclusion criteria

1. Patients who are unable to maintain a sitting position for 30 minutes.
2. Patients who are unable to walk even with walking aids.
3. Patients who can't understand the exercise procedure.
4. Patients who can't receive rehabilitation treatments.
5. Inappropriate patients due to complications judged by a doctor and/or a therapist.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Kubota

Organization

Kochi University, Kochi Medical School Hospital

Division name

Department of Hematology and Respiratory Medicine

Zip code


Address

185-1 Kohasu Okocho, Nankoku city, Kochi

TEL

088-880-2345

Email

kubotat@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiya Morishita

Organization

Healthcare corporation Usuikai Tano Hospital

Division name

Department of Rehabilitation

Zip code


Address

1414-1 Tano town, Aki county, Kochi

TEL

0887-38-7111

Homepage URL


Email

morishi2007@yahoo.co.jp


Sponsor or person

Institute

Kochi University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Healthcare corporation Usuikai Tano Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

医療法人臼井会田野病院(高知県)Healthcare corporation Usuikai Tano Hospital (Kochi)


Other administrative information

Date of disclosure of the study information

2015 Year 01 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

Although pulmonary function tests showed slight improvements, these results were not clinically significant.

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

Completed

Date of protocol fixation

2014 Year 10 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 30 Day

Last modified on

2018 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018238


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name