Pituitary AdenomaNCT04284605
Effects Exercise Training in Patients With Pituitary Adenoma
A study testing Aerobic exercise combined with strength training and Yoga in people with Pituitary Adenoma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Aerobic exercise combined with strength training and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- volunteers
- macroadenomas
- at least 1 hormonal axis affected
- Karnofsky Perfomance Scale between 70-100
- 18-65 years
- approved by cardiologists
Who cannot join
- regular exercise habit
- acute pain in many part of the body
- additional neurologic condititons
- any rheumatological and immunologic conditions
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Pituitary Adenoma
- Being tested
- Aerobic exercise combined with strength training, Yoga
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
YogaOther
60 minute yoga intervention including different asanas, breath control and meditation
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Not described Receives: Other: Aerobic exercise combined with strength training; Other: Yoga |
| Group2 | Experimental | Not described Receives: Other: Aerobic exercise combined with strength training; Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Factors
Concentrations of IL6, IL1beta, TNFalfa in serum
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start15 May 2020
- Primary completion15 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Dülger, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284605
- Sponsor's protocol ID
- KA-180156
- Status last verified
- Oct 2021
- First submitted
- 24 Feb 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04284605
- Acronym / sponsor ID
- KA-180156
- Conditions
- Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Other: Aerobic exercise combined with strength training, Other: Yoga |
| Group2 | Experimental | Other: Aerobic exercise combined with strength training, Other: Yoga |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- volunteers
- macroadenomas
- at least 1 hormonal axis affected
- Karnofsky Perfomance Scale between 70-100
- 18-65 years
Key exclusion criteria (4 listed)
- regular exercise habit
- acute pain in many part of the body
- additional neurologic condititons
- any rheumatological and immunologic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise combined with strength training30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles. | Other | Group1, Group2 |
| Yoga60 minute yoga intervention including different asanas, breath control and meditation | Other | Group1, Group2 |
Primary outcome
Biochemical Factors
Time frame: 6 weeks
Concentrations of IL6, IL1beta, TNFalfa in serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No. no IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise combined with strength training and Yoga in people with Pituitary Adenoma, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Factors (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.