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CompletedNCT06605846Updated Apr 2, 2025

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

An interventional study of otago excercises and Medical ADT treatment in Prostate, sponsored by MTI University. Completed at 1 site in Egypt. Open to male participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by MTI University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
Male
01

Study 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.

Read the 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

02

Conditions studied

  • Prostate

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Keywords

  • Androgen deprivation therapy
  • otago excercises
  • prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 110 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

MTI University is the lead sponsor of 58 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
110 participants (actual)

Study arms

  • 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

  • Sham comparator
    control

    This group included 52 patients receive routine medical care for prostatic cancer patients.

    Other: Medical ADT treatment

Interventions

  • Otherotago 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

  • OtherMedical ADT treatment

    Medical ADT treatment according to patient age, prostatic cancer stage

    Also known as: control

06

What researchers measure

Primary outcomes

  1. Isometric knee muscle strength

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

    Time frame: base line and 24 weeks

  2. Bone mineral density (BMD

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

    Time frame: base line and 24 weeks

Secondary outcomes

  1. 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

    Time frame: base line and 24weeks

  2. Berg Balance Scale (BBS)

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

    Time frame: base line and 24weeks

07

Study locations

1 site
  • MTI university
    Multiple Locations, 11511, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06605846
Lead sponsor
MTI University
Responsible party
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d (lectrurer of physical therapy for general surgery, MTI University) — Principal investigator
First posted
Sep 20, 2024
Start date
Sep 23, 2024
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025
Last update
Apr 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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