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

NCT06605846 | Completed

• 1 other identifier: P.T.REC/012/005337
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate

Keywords

Androgen deprivation therapy; otago excercises; prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Timed up and go (TUG) test

  base line and 24weeks

• Berg Balance Scale (BBS)

  base line and 24weeks

Study Arms (2)

Otago exercise training

EXPERIMENTAL

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

control

SHAM COMPARATOR

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

Other: Medical ADT treatment

Interventions

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

Otago exercise training

Medical ADT treatment OTHER

Medical ADT treatment according to patient age, prostatic cancer stage

Also known as: control

control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

MTI university

Multiple Locations, 11511, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectrurer of physical therapy for general surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: September 23, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)