NCT04284605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

February 24, 2020

Last Update Submit

October 26, 2021

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

  • Biochemical Factors

    Concentrations of IL6, IL1beta, TNFalfa in serum

    6 weeks

Study Arms (2)

Group1

EXPERIMENTAL
Other: Aerobic exercise combined with strength trainingOther: Yoga

Group2

EXPERIMENTAL
Other: Aerobic exercise combined with strength trainingOther: Yoga

Interventions

Aerobic exercise combined with strength trainingOTHER

30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles.

Group1Group2
YogaOTHER

60 minute yoga intervention including different asanas, breath control and meditation

Group1Group2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Resistance TrainingYoga

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesSpiritual TherapiesExercise Movement Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

May 15, 2020

Primary Completion

September 15, 2021

Study Completion

October 15, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

no IPD will be shared

Locations

TU(1)