ProstateNCT06605846
Otago Exercises on the Risk of Falling in Prostatic Cancer Patients Receiving Androgen Deprivation Therapy
A study testing otago excercises and Medical ADT treatment in people with Prostate, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate
- What is being tested?
- otago excercises and Medical ADT treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Sep 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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.
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
- Conditions
- Prostate
- Being tested
- otago excercises, Medical ADT treatment
- Keywords
- Androgen deprivation therapy, otago excercises, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otago excercisesOther
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 treatmentOther
Also called control
Medical ADT treatment according to patient age, prostatic cancer stage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: otago excercises |
| control | Sham comparator | This group included 52 patients receive routine medical care for prostatic cancer patients. Receives: Other: Medical ADT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric knee muscle strength
will be used to evaluate knee extension and flexion isometric strength.
Measured: 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)
Measured: base line and 24 weeks
Secondary outcomes (2)
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
Measured: 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
Measured: base line and 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start23 Sep 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605846
- Sponsor's protocol ID
- P.T.REC/012/005337
- Status last verified
- Mar 2025
- First submitted
- 18 Sep 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otago Exercises on the Risk of Falling in Prostatic Cancer Patients Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT06605846
- Acronym / sponsor ID
- P.T.REC/012/005337
- Conditions
- Prostate
- Keywords
- Androgen deprivation therapy, otago excercises, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Otago exercise training | Experimental | Other: otago excercisesThis group included 52 patients receive Otago exercise training for 45 minutes after each session with routine medical care for prostatic cancer patients |
| control | Sham comparator | Other: Medical ADT treatmentThis group included 52 patients receive routine medical care for prostatic cancer patients. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged 50 years or older diagnosed with adenocarcinoma prostate cancer.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| otago excercisesOtago 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 | Other | Otago exercise training |
| Medical ADT treatmentAlso: controlMedical ADT treatment according to patient age, prostatic cancer stage | Other | control |
Primary outcome
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)
2 secondary outcomes
Timed up and go (TUG) test
Time frame: base line and 24weeks
Berg Balance Scale (BBS)
Time frame: base line and 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing otago excercises and Medical ADT treatment in people with Prostate, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric knee muscle strength (time frame: base line and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.