Physical Activity Clinical Trial
Official title:
Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients: a Phase I Prescription Dose Escalation Trial
Verified date | December 2022 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Recent drug improvement (e.g. abiraterone or enzalutamide) for castration resistant prostate cancer (CRPC) patients has improved survival. As treatment strategies improve and patients live longer, patients must cope with their treatment-induced adverse effects. Improving levels of physical activity (PA) and less amounts of sitting time (e.g. sedentary behavior, SB) could have a positive impact on patient's health, non-cancer mortality, and quality of life and potentially improve survival. The role of PA has not yet been examined in CRPC patients, which is a clear unmet need. No specific PA guidelines exist for CRPC patients, but specific guidelines are warranted because of advanced disease stage, reduced performance score and comorbidity. It is to be expected that the PA level of CRPC patients is lower compared to non-CRPC patients receiving androgen deprivation therapy (ADT). This study aims to determine the optimal starting physical therapy prescription in CRPC patients receiving second line hormone treatment.
Status | Completed |
Enrollment | 9 |
Est. completion date | June 15, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - CRPC patients with second-line hormone treatment - Able to walk 400 meters without help from another person - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial) - =4 weeks since any major surgery and fully recovered before patient registration - Written informed consent must be given according to International conference on harmonization Good Clinical Practice and national regulation. Exclusion Criteria: - Musculoskeletal, cardiovascular or neurological comorbidity that prevent the patient to participate in an exercise program - Painful bone metastases (VAS) at the time of inclusion - Unstable bone metastases (SINS classification) at time of inclusion |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital ghent | Ghent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose based on tolerance | Maximum tolerated dose will be assessed by borg scale of perceived exertion. | change before and after 1 exercise session (at one day) | |
Primary | Maximum tolerated dose based on safety | Maximum tolerated dose will be assessed by CTCAE | change before and after 1 exercise session (at one day) | |
Primary | Maximum tolerated dose based on safety | Maximum tolerated dose will be assessed by VAS | change before and after 1 exercise session (at one day) | |
Secondary | Functionality | Functionality will be assessed by the Karnofsky Performance Status | baseline | |
Secondary | Pain | Pain will be assessed by the Brief pain inventory (BPI) questionnaire | baseline | |
Secondary | Health Related quality of Life general | HRQoL will be assessed by the EORTC quality of life (QLQ) C30 questionnaire | baseline | |
Secondary | Health Related quality of Life disease specific | HRQoL will be assessed by the EORTC quality of life prostate 25 questionnaire | baseline | |
Secondary | Physical activity level by International Physical Activity Questionnaire (IPAQ) | Physical activity level will be assessed by the IPAQ questionnaire | baseline | |
Secondary | Physical activity level by Godin | Physical activity level will be assessed by the Godin Leisure questionnaire | baseline | |
Secondary | Body composition | Body composition will be assessed by 8-point bioelectrical impedance analysis | baseline | |
Secondary | Physical performance | Physical performance will be assessed by the 400m walk test | baseline | |
Secondary | Physical performance by time up and go | Physical performance will be assessed by the time up and go test | baseline | |
Secondary | Physical performance by 6m walk | Physical performance will be assessed by the 6-meter walk test usual and fast pace | baseline | |
Secondary | Physical performance by 6 m walk backward | Physical performance will be assessed by the 6 meter backward walk | baseline | |
Secondary | Physical performance by Cardiopulmonary Exercise Testing (CPET) | Physical performance will be assessed by the CPET | baseline | |
Secondary | Balance by four square test | Balance will be assessed by the four square test | baseline | |
Secondary | Balance by chair rise test | Balance will be assessed by the chair rise test | baseline | |
Secondary | Motivation 1 | Motivation will be assessed by the stages of change theory | baseline | |
Secondary | Motivation 2 | Motivation will be assessed by the Exercise Motivation Inventory questionnaire | baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A |