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Trial Title:
Otago Exercises on the Risk of Falling in Prostatic Cancer Patients Receiving Androgen Deprivation Therapy
NCT ID:
NCT06605846
Condition:
Prostate
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Androgen deprivation therapy
otago excercises
prostate cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
otago excercises
Description:
Otago training is helpful, and one of the most powerful interventions where the original
randomized controlled trials reported improvements in functional outcomes and a 35%
reduction in falls for frail, high-risk older adults (Shubert et al., 2018). In Egypt,
there are little researches about Otago Exercise Program.
Exercise is well-known as an economic and key adjuvant treatment in clinical oncology
that improves QOL of cancer survivors. Many studies focused on investigating the benefits
of exercise interventions on preventing falls and improving physical performance of older
adults. Combination of strength and functional balance exercise has been demonstrated as
an effective method to improve balance performance, rather than strength training alone
Arm group label:
Otago exercise training
Intervention type:
Other
Intervention name:
Medical ADT treatment
Description:
Medical ADT treatment according to patient age, prostatic cancer stage
Arm group label:
control
Other name:
control
Summary:
Androgen deprivation therapy (ADT) is a common treatment for older men with advanced
prostate cancer (PCa) but is associated with numerous deleterious health effects that may
accentuate age associated physiological declines.
Decreased lower body muscle mass and strength, cognitive decline, worsen fatigue and
progressive loss of BMD following initiating ADT could put prostate cancer survivors at
higher risk of impaired physical functioning performance and subsequently developing
falls. Otago training is helpful, and one of the most powerful interventions where the
original randomized controlled trials reported improvements in functional outcomes and a
35% reduction in falls for frail, high-risk older adults (Shubert et al., 2018). In
Egypt, there are little researches about Otago Exercise Program.
Detailed description:
Androgen deprivation therapy (ADT) is a common treatment for older men with advanced
prostate cancer (PCa) but is associated with numerous deleterious health effects that may
accentuate age associated physiological declines.
Decreased lower body muscle mass and strength, cognitive decline, worsen fatigue and
progressive loss of BMD following initiating ADT could put prostate cancer survivors at
higher risk of impaired physical functioning performance and subsequently developing
falls.
Otago training is helpful, and one of the most powerful interventions where the original
randomized controlled trials reported improvements in functional outcomes and a 35%
reduction in falls for frail, high-risk older adults (Shubert et al., 2018). In Egypt,
there are little researches about Otago Exercise Program.
Exercise is well-known as an economic and key adjuvant treatment in clinical oncology
that improves QOL of cancer survivors. Many studies focused on investigating the benefits
of exercise interventions on preventing falls and improving physical performance of older
adults. Combination of strength and functional balance exercise has been demonstrated as
an effective method to improve balance performance, rather than strength training alone
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Men aged 50 years or older diagnosed with adenocarcinoma prostate cancer.
- Will initiate and receive continuous ADT (luteinizing hormone releasing hormone
agonist (LHRH) or combination of LHRH and anti-androgen) for at least 6 months
after recruitment.
- Report > 1 fall in the past year OR have a score on one of two physical
performance tests that is associated with increased fall risk (i.e., ≥ 12.0 s
to complete the 3 m timed up and go (TUG)
- Willing to attend >75% of intervention Otago exercises
Exclusion Criteria:
- severe cardiac disease (New York Heart Association class III or greater), angina,
- uncontrolled hypertension (blood pressure > 160/95 mmHg), moderate to severe
aortic stenosis, acute illness or fever, uncontrolled atrial or ventricular
dysrhythmias, uncontrolled sinus tachycardia (> 120 beats per minute),
third-degree atrioventricular heart block
- lower limb fracture within last 3 months , lower limb amputation
Gender:
Male
Gender based:
Yes
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
MTI university
Address:
City:
Multiple Locations
Zip:
11511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Ahmed Mohamed lecturer of physical therapy for general surgery, Phd
Phone:
00201097782441
Email:
nn_ee_mm_oo@yahoo.com
Contact backup:
Last name:
Heba M Lecturer at basic sciences at faculty of physical therapy cair, Phd
Investigator:
Last name:
Ahmed M lecturer of phyasiical therapy, Phd
Email:
Principal Investigator
Start date:
September 23, 2024
Completion date:
May 20, 2025
Lead sponsor:
Agency:
MTI University
Agency class:
Other
Source:
MTI University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06605846
