Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163261
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-11-30
Brief Title:
Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Individualized and Person-centred Physical Activity and Exercise for Patients With Non Functioning Pituitary Adenoma - A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about physical activitys effect on health in people who have had surgery of a non-functioning pituitary adenoma
The main questions it aims to answer are
Do physical activity increase quality of life
Do physical activity increase general health cardiovascular fitness self-efficacy and muscle strength and reduce fatigue and cardiovascular risk profile
Participants will at the start of the the study at 6 months follow up and 12 months follow up
Fill out health surveys
Perform a cycling test hand strength test chair stand test and wear and accelerometer for a week
Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass
Leave blood samples
Researchers will compare those who are randomized to the intervention and see a physiotherapist to get an individualized and person-centred prescription of physical activity plan and those who are randomized not to be in the intervention to see if physical activity increases quality of life and general health
The main questions it aims to answer are
Do physical activity increase quality of life
Do physical activity increase general health cardiovascular fitness self-efficacy and muscle strength and reduce fatigue and cardiovascular risk profile
Participants will at the start of the the study at 6 months follow up and 12 months follow up
Fill out health surveys
Perform a cycling test hand strength test chair stand test and wear and accelerometer for a week
Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass
Leave blood samples
Researchers will compare those who are randomized to the intervention and see a physiotherapist to get an individualized and person-centred prescription of physical activity plan and those who are randomized not to be in the intervention to see if physical activity increases quality of life and general health
Detailed Description:
This study is an unblinded prospective randomized controlled trial where 120 participants will be assigned to either an intervention group or a control group - 60 in each arm The intervention will receive an individualized and person-centred prescription of physical activity and exercise The control group will get standard care
Inclusion criteria
Patients with non-functioning pituitary adenoma treated with surgery the last ten years
Stable hormone replacement therapy 6 months
Age 18-75 years
Ability to communicate in Swedish
Exclusion criteria
Patients with other pituitary tumours than non-functioning pituitary adenoma
Patients who could need tumour intervention surgery or radiotherapy within one year
Co-morbidities that could have significant impact on the outcome variables
After the randomization patients in intervention arm will meet a physiotherapist and a research nurse The participants will be asked to describe their life situation and experiences regarding their health diseases physical activity and exercise and after this be given an individualized and person-centred prescription of physical activity The exercise will be documented in the self-care plan In order to assess participants adherence to exercise participants will be informed to document their performed exercise in the self-care plan during the first 12 weeks All patients in the intervention group will be followed at 4 8 and 12 weeks after inclusion in the study when they meet with the same nurse and physiotherapist as at the first visit
Regarding outcome measures the primary endpoint and the secondary endpoints and will be measured at baseline and at 6 and 12 months for both the intervention group and the standard care group The primary endpoint is quality of life and the secondary endpoints are changes in health status physical activity cardiorespiratory fitness muscle strength self-reported fatigue and self-efficacy and changes in cardiovascular risk profile
To assess this the participant will
Fill out health surveys
Perform a cycling test hand strength test chair stand test and wear and accelerometer for a week
Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass
Leave blood samples
Inclusion criteria
Patients with non-functioning pituitary adenoma treated with surgery the last ten years
Stable hormone replacement therapy 6 months
Age 18-75 years
Ability to communicate in Swedish
Exclusion criteria
Patients with other pituitary tumours than non-functioning pituitary adenoma
Patients who could need tumour intervention surgery or radiotherapy within one year
Co-morbidities that could have significant impact on the outcome variables
After the randomization patients in intervention arm will meet a physiotherapist and a research nurse The participants will be asked to describe their life situation and experiences regarding their health diseases physical activity and exercise and after this be given an individualized and person-centred prescription of physical activity The exercise will be documented in the self-care plan In order to assess participants adherence to exercise participants will be informed to document their performed exercise in the self-care plan during the first 12 weeks All patients in the intervention group will be followed at 4 8 and 12 weeks after inclusion in the study when they meet with the same nurse and physiotherapist as at the first visit
Regarding outcome measures the primary endpoint and the secondary endpoints and will be measured at baseline and at 6 and 12 months for both the intervention group and the standard care group The primary endpoint is quality of life and the secondary endpoints are changes in health status physical activity cardiorespiratory fitness muscle strength self-reported fatigue and self-efficacy and changes in cardiovascular risk profile
To assess this the participant will
Fill out health surveys
Perform a cycling test hand strength test chair stand test and wear and accelerometer for a week
Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass
Leave blood samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None