UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046949
Receipt number R000053571
Scientific Title effect of 8 weeks of endurance exercise and respiratory muscle training on the lung function of male mountaineers of Shahroud City.
Date of disclosure of the study information 2022/02/22
Last modified on 2022/02/19 20:17:39

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Basic information

Public title

Mohseni

Acronym

Mrs Mohseni

Scientific Title

effect of 8 weeks of endurance exercise and respiratory muscle training on the lung function of male mountaineers of Shahroud City.

Scientific Title:Acronym

effect of 8 weeks of endurance exercise and respiratory muscle training on the lung function of male mountaineers of Shahroud City.

Region

Asia(except Japan)


Condition

Condition

in progress

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to evaluate the effect of 8 weeks of endurance exercise and respiratory muscle training on the lung function of male mountaineers of Shahroud City.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Respiratory indices SVC (P = 0.0001), FVC (P = 0.009), FEV1 (P = 0.006), PEF (P = 0.003), %25-%75 FEF (P = 0.0001), MVV (P = 0.011), and VO2max (P = 0.046) There was a significant difference in the group of respiratory muscle exercises. But in the endurance training group, there was a significant difference only in MVV (P = 0.024) indices.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

aerobic training

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

38 years-old <=

Age-upper limit

55 years-old >=

Gender

Male

Key inclusion criteria

healthy taking part in sessions

Key exclusion criteria

absence in sessions

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Elham
Middle name
Last name Vosadi

Organization

shahrood university of technology

Division name

Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences

Zip code

1346638387

Address

Shahrood, 7tir square,

TEL

09122473229

Email

e.vosadi@shahroodut.ac.ir


Public contact

Name of contact person

1st name mina
Middle name
Last name haghighi

Organization

Shahrood University of Technology

Division name

Physical Education and Sport Sciences Faculty, Biological Sciences Department,

Zip code

1346638387

Address

Shahrood, 7tir square,

TEL

09305611550

Homepage URL


Email

mina7679@yahoo.com


Sponsor or person

Institute

Shahrood university of technology

Institute

Department

Personal name



Funding Source

Organization

Shahrood University of technology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shahrood University of Technology

Address

Shahrood, 7tir square,

Tel

09305611550

Email

mina7679@yahoo.com


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

2022 Year 02 Month 22 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

Open public recruiting

Date of protocol fixation

2021 Year 09 Month 22 Day

Date of IRB

2021 Year 10 Month 22 Day

Anticipated trial start date

2021 Year 11 Month 19 Day

Last follow-up date

2022 Year 03 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 02 Month 19 Day

Last modified on

2022 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053571