ElderlyPhase 1/2NCT01057056
The Role of Mind Body Therapy in Geriatric Rehabilitation
A Phase 1/2 study testing mind-body intervention in people with Elderly and Treatment, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background: The main goal of geriatric rehabilitation reconditioning following an acute illness is rapid restoration of normal activity. Key elements are pain control, restoration of bowel functions, sleep, appetite and general well-being, along side the physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- mind-body intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2010to not given
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- suitable candidates had to be aged 18 years or older
- treated in the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) and
- were willing and able to complete the study protocol.
Who cannot join
- severe unstable chronic illness (e.g., congestive heart failure, chronic renal failure, cancer).
About this study
Background: The main goal of geriatric rehabilitation reconditioning following an acute illness is rapid restoration of normal activity. Key elements are pain control, restoration of bowel functions, sleep, appetite and general well-being, along side the physical activity.
Objective: To assess the effect of mind-body intervention as an adjunct to medical and physical rehabilitation in geriatric patients.
Design: Prospective study Setting: University affiliated large city general hospital
- Being tested
- mind-body intervention
- Keywords
- patients in a sub-acute geriatric rehabilitation department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mind-body interventionOther
multi-disciplinary mind-body intervention including: breathing techniques, guided imagery, meditation, touch therapy
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | control group - receiving standard treatment Receives: Other: mind-body intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being: Short Form-36 (SF-36), Geriatric Depression Scale (GDS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057056
- Sponsor's protocol ID
- TASMC-09-YL-0488-CTIL
- Other IDs
- 0488-09-TLV
- Status last verified
- Jan 2010
- First submitted
- 26 Jan 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mind Body Therapy in Geriatric Rehabilitation
- ClinicalTrials.gov ID
- NCT01057056
- Acronym / sponsor ID
- TASMC-09-YL-0488-CTIL
- Keywords
- patients in a sub-acute geriatric rehabilitation department
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2010
- First posted
- 27 Jan 2010 (estimated)
- 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.
Background: The main goal of geriatric rehabilitation reconditioning following an acute illness is rapid restoration of normal activity. Key elements are pain control, restoration of bowel functions, sleep, appetite and general well-being, along side the physical activity.
Objective: To assess the effect of mind-body intervention as an adjunct to medical and physical rehabilitation in geriatric patients.
Design: Prospective study Setting: University affiliated large city general hospital
Study design
- Primary purpose
- Supportive care
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | Other: mind-body interventioncontrol group - receiving standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suitable candidates had to be aged 18 years or older
- treated in the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) and
- were willing and able to complete the study protocol.
Key exclusion criteria (1 listed)
- severe unstable chronic illness (e.g., congestive heart failure, chronic renal failure, cancer).
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 |
|---|---|---|
| mind-body interventionmulti-disciplinary mind-body intervention including: breathing techniques, guided imagery, meditation, touch therapy | Other | control group |
Primary outcome
Well-being: Short Form-36 (SF-36), Geriatric Depression Scale (GDS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mind-body intervention in people with Elderly and Treatment, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Well-being: Short Form-36 (SF-36), Geriatric Depression Scale (GDS). 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 5 Feb 2010.