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The goal of this clinical trial is to learn about physical activity's effect on health in people who have had surgery of a non-functioning pituitary adenoma.
The main questions it aims to answer are:
Participants will at the start of the the study, at 6 months follow up and 12 months follow up:
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.¨.
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
Exclusion criteria
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Other | This group will receive an individualized and person-centred prescription of physical activity and exercise in addition to standard care. |
|
| Control group | No Intervention | This group will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Other | The intervention group will receive an individualized and person-centred prescription of physical activity and exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life | Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life.. | At baseline |
| Changes in quality of life | Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life.. | At 6 months follow up |
| Changes in quality of life | Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life.. | At 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in health status | Measured with EuroQol-5D (EQ5D). The EuroQol-5D (EQ-5D) index ranges from 0 to 1, where 1 represents the best possible health state, and a visual analog scale (VAS), a scale from 0 to 100, with 100 representing the best imaginable health state. | At baseline |
| Changes in health status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Hantelius, Md | Contact | +46704442085 | victor.hantelius@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Univesity Hospital | Recruiting | Gothenburg | Västra Götaland County | 41345 | Sweden |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Measured with EuroQol-5D (EQ5D). The EuroQol-5D (EQ-5D) index ranges from 0 to 1, where 1 represents the best possible health state, and a visual analog scale (VAS), a scale from 0 to 100, with 100 representing the best imaginable health state. |
| At 6 months follow up |
| Changes in health status | Measured with EuroQol-5D (EQ5D). The EuroQol-5D (EQ-5D) index ranges from 0 to 1, where 1 represents the best possible health state, and a visual analog scale (VAS), a scale from 0 to 100, with 100 representing the best imaginable health state. | At 12 months follow up |
| Changes in fitness/muscle strength - Cycling | Cycling test | At baseline |
| Changes in fitness/muscle strength - Cycling | Cycling test | At 6 months follow-up |
| Changes in fitness/muscle strength - Cycling | Cycling test | At 12 months follow up |
| Changes in fitness/muscle strength - Hand strength | Hand strength test | At baseline |
| Changes in fitness/muscle strength - Hand strength | Hand strength test | At 16 months follow up |
| Changes in fitness/muscle strength - Hand strength | Hand strength test | At 12 months follow up |
| Changes in fitness/muscle strength - Chair stand | Chair stand test | At baseline |
| Changes in fitness/muscle strength - Chair stand | Chair stand test | At 6 months follow up |
| Changes in fitness/muscle strength - Chair stand | Chair stand test | At 12 months follow up |
| Changes in fitness/muscle strength - Accelerometer | Accelerometer for a week | At baseline |
| Changes in fitness/muscle strength - Accelerometer | Accelerometer for a week | At 6 months follow up |
| Changes in fitness/muscle strength - Accelerometer | Accelerometer for a week | At 12 months follow up |
| Changes in self-reported self-efficacy | Self-reported self-efficacy through Self-Efficacy t Manage Chronic Disease (a questionnaire with 6 question where you rate yourself 1-10) | At baseline |
| Changes in self-reported self-efficacy | Self-reported self-efficacy through Self-Efficacy t Manage Chronic Disease (a questionnaire with 6 question where you rate yourself 1-10) | At 6 months follow up |
| Changes in self-reported self-efficacy | Self-reported self-efficacy through Self-Efficacy t Manage Chronic Disease (a questionnaire with 6 question where you rate yourself 1-10) | At 12 months follow up |
| Changes in cardiovascular risk profile - Blood pressure | Blood pressure - systolic and diastolic | At baseline |
| Changes in cardiovascular risk profile - Blood pressure | Blood pressure - systolic and diastolic | At 6 months follow up |
| Changes in cardiovascular risk profile - Blood pressure | Blood pressure - systolic and diastolic | At 12 months follow up |
| Changes in cardiovascular risk profile - Blood samples | Blood lipids | At baseline |
| Changes in cardiovascular risk profile - Blood samples | Blood lipids | At 6 months follow up |
| Changes in cardiovascular risk profile - Blood samples | Blood lipids | At 12 months follow up |