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.

Study Overview

• Status: Completed
• Conditions: Prostate
• Intervention / Treatment: Other: otago excercises; Other: Medical ADT treatment

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Multiple Locations, Egypt, 11511
    • MTI University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otago exercise training; This group included 52 patients receive Otago exercise training for 45 minutes after each session with routine medical care for prostatic cancer patients	Other: otago excercises; 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
Sham Comparator: control; This group included 52 patients receive routine medical care for prostatic cancer patients.	Other: Medical ADT treatment; Medical ADT treatment according to patient age, prostatic cancer stage; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric knee muscle strength	will be used to evaluate knee extension and flexion isometric strength.	base line and 24 weeks
Bone mineral density (BMD	will be used to evaluate Bone mineral density of the lumbar spine (LS) and femoral neck (FN)	base line and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go (TUG) test	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	base line and 24weeks
Berg Balance Scale (BBS)	Used to assess the patient ability to balance his /her body during activities and risk of fall	base line and 24weeks

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; Androgen deprivation therapy; otago excercises
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: P.T.REC/012/005337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No