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This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.
This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.
In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-week aerobic exercise and cognitive-behavioral therapy | Experimental | 12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions |
|
| Control group | No Intervention | Patients assigned to the control group will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week aerobic exercise and cognitive-behavioral therapy | Behavioral | 12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep | Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group | Change from baseline sleep at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group | Baseline, 12-weeks |
| Fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoffer Johansen, PhD, Dr.Med | Danish Cancer Society Research Center | Principal Investigator |
| Katrine Løppenthin, PhD | Danish Cancer Society Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department | Næstved | Denmark |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Measured by the multidimensional fatigue inventory, to investigate change in fatigue from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
| Baseline, 12 weeks, 6 month |
| Physical activity | Measured by the Physical activity Questionnaire to investigate change in physical activity from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Depression | Measured by the Patient Health Questionnaireto, to investigate change in depression from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Anxiety | Measured by the Generalized Anxiety Disorder Questionnaireto, to investigate change in anxiety from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Stress | Measured by Perceived Stress Scale to investigate change in stress from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Quality of life | Measured by European Organization for Research and Treatment Cancer, to investigate change in quality of life from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Sleep quality | Measured by Pittsburgh Sleep Quality Index, to investigate change in sleep quality from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Sleep pattern | Measured by a sleep diary, to investigate change in sleep pattern from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Insomnia | Measured by Insomnia Severity Index, to investigate change in insomnia from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group | Baseline, 12 weeks, 6 month |
| Physical activity | Measured by actigraphy, to investigate change in physical activity from baseline to 12 weeks and the difference in change between intervention - and the control group | Baseline, 12 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |