Effects Exercise Training in Patients With Pituitary Adenoma | NCT04284605

Studies
Effects Exercise Training in Patients With Pituitary Adenoma

NCT04284605

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Oct 27, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Pituitary Adenoma

Interventions

Aerobic exercise combined with strength training
Yoga

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Sep 15, 2021Actual

Completion Date

Oct 15, 2021Actual

First Submitted Date

Feb 24, 2020

First Submission Date that Met QC Criteria

Feb 24, 2020

First Posted Date

Feb 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2021

Last Update Posted Date

Oct 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma.

H2: Aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma.

H3: Aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma.

H4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on quality of life in people with pituitary adenoma. H7: Aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group1	Experimental		Other: Aerobic exercise combined with strength training Other: Yoga
Group2	Experimental		Other: Aerobic exercise combined with strength training Other: Yoga

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic exercise combined with strength training	Other	30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biochemical Factors	Concentrations of IL6, IL1beta, TNFalfa in serum	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

volunteers
macroadenomas
at least 1 hormonal axis affected
Karnofsky Perfomance Scale between 70-100
18-65 years
approved by cardiologists

Exclusion Criteria:

regular exercise habit
acute pain in many part of the body
additional neurologic condititons
any rheumatological and immunologic conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara	Çankaya	06530	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

no IPD will be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010911	Pituitary Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training
D015013	Yoga

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided