Clinical trial NCT06605846: Otago Exercises on the Risk of Falling in Prostatic Cancer Patients Receiving Androgen Deprivation Therapy
Official title: Otago Exercises on the Risk of Falling in Prostatic Cancer Patients Receiving Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate
Keywords: Androgen deprivation therapy
otago excercises
prostate cancer
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 110
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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

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 \&amp;gt; 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 \&amp;gt;75% of intervention Otago exercises

Exclusion Criteria:

* severe cardiac disease (New York Heart Association class III or greater), angina,
* uncontrolled hypertension (blood pressure \&amp;gt; 160/95 mmHg), moderate to severe aortic stenosis, acute illness or fever, uncontrolled atrial or ventricular dysrhythmias, uncontrolled sinus tachycardia (\&amp;gt; 120 beats per minute), third-degree atrioventricular heart block
* lower limb fracture within last 3 months , lower limb amputation

Primary outcomes:
measure: Isometric knee muscle strength
timeFrame: base line and 24 weeks
measure: Bone mineral density (BMD
timeFrame: base line and 24 weeks
Secondary outcomes:
measure: Timed up and go (TUG) test
timeFrame: base line and 24weeks
measure: Berg Balance Scale (BBS)
timeFrame: base line and 24weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Egypt
facility: MTI university
Study officials:
References: