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Completed

NCT Number: NCT06605846

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

MTI university

Multiple Locations, 11511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

otago excercises

Other

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

Medical ADT treatment

Other

Medical ADT treatment according to patient age, prostatic cancer stage

Other names: control

Primary outcomes

  1. Isometric knee muscle strength

    Time frame: base line and 24 weeks

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

  2. 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

  1. Timed up and go (TUG) test

    Time frame: base line and 24weeks

    will be used to measure basic mobility skills. The measurement outcome for TUG is the time it takes to rise up out of a chair, walk 3 m away from the chair, walk 3 m back to the chair, and return to the seated position

  2. Berg Balance Scale (BBS)

    Time frame: base line and 24weeks

    Used to assess the patient ability to balance his /her body during activities and risk of fall

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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