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Clinical Trials/NCT06605846
NCT06605846
Completed
Not Applicable

Otago Exercises on the Risk of Falling in Prostatic Cancer Patients Receiving Androgen Deprivation Therapy

MTI University1 site in 1 country110 target enrollmentSeptember 23, 2024
ConditionsProstate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate
Sponsor
MTI University
Enrollment
110
Locations
1
Primary Endpoint
Isometric knee muscle strength
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
September 23, 2024
End Date
April 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d

lectrurer of physical therapy for general surgery

MTI University

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

Outcomes

Primary Outcomes

Isometric knee muscle strength

Time Frame: base line and 24 weeks

will be used to evaluate knee extension and flexion isometric strength.

Bone mineral density (BMD

Time Frame: base line and 24 weeks

will be used to evaluate Bone mineral density of the lumbar spine (LS) and femoral neck (FN)

Secondary Outcomes

  • Timed up and go (TUG) test(base line and 24weeks)
  • Berg Balance Scale (BBS)(base line and 24weeks)

Study Sites (1)

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