Effects Exercise Training in Patients With Pituitary Adenoma
Primary Purpose
Pituitary Adenoma
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise combined with strength training
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Adenoma
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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group1
Group2
Arm Description
Outcomes
Primary Outcome Measures
Biochemical Factors
Concentrations of IL6, IL1beta, TNFalfa in serum
Secondary Outcome Measures
Full Information
NCT ID
NCT04284605
First Posted
February 24, 2020
Last Updated
October 26, 2021
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT04284605
Brief Title
Effects Exercise Training in Patients With Pituitary Adenoma
Official Title
Effects of Aerobic Training Combined With Strength Training and Yoga on Biochemical Factors, Physical Performance and Quality of Life in Patients With Pituitary Adenoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group1
Arm Type
Experimental
Arm Title
Group2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Aerobic exercise combined with strength training
Intervention Description
30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
60 minute yoga intervention including different asanas, breath control and meditation
Primary Outcome Measure Information:
Title
Biochemical Factors
Description
Concentrations of IL6, IL1beta, TNFalfa in serum
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06530
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no IPD will be shared
Learn more about this trial
Effects Exercise Training in Patients With Pituitary Adenoma
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