AgingNCT01867112
Physical Activity for Improving Quality of Life and Reducing Frailty in Advanced Age
A study testing Physical Activity in people with Aging, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the connection between level of physical activity and health parameters, quality of life, and frailty. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Jul 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age above 65
- Able to undergo graded stress exam
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Zinman College for Physical Education and Sport Sciences
Ramot Naftali, 42902
About this study
Official title: Physical Activity for Improving Quality of Life and Reducing Frailty in Advanced Age: Individually Tailored Program vs the General Guidelines Recommended by Offical Health Organizations.
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the connection between level of physical activity and health parameters, quality of life, and frailty.
- Conditions
- Aging
- Being tested
- Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Physical activity either by individualized program or general guidelines
| Study group | Role | What they receive |
|---|---|---|
| Individualized Program | Active comparator | Based on personal fitness an individualized physical activity program will be built and followed by each individual in the arm Receives: Behavioral: Physical Activity |
| General Physical Activity Guidelines | Active comparator | The entire group of individuals in this arm will follow a physical activity program according to the General Physical Activity Guidelines Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Fitness
Aerobic fitness will be measured with a graded stress exam
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867112
- Sponsor's protocol ID
- HYMC-26-13
- Status last verified
- May 2013
- First submitted
- 29 May 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity for Improving Quality of Life and Reducing Frailty in Advanced Age: Individually Tailored Program vs the General Guidelines Recommended by Offical Health Organizations.
- ClinicalTrials.gov ID
- NCT01867112
- Acronym / sponsor ID
- HYMC-26-13
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Jun 2013 (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.
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the connection between level of physical activity and health parameters, quality of life, and frailty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Program | Active comparator | Behavioral: Physical ActivityBased on personal fitness an individualized physical activity program will be built and followed by each individual in the arm |
| General Physical Activity Guidelines | Active comparator | Behavioral: Physical ActivityThe entire group of individuals in this arm will follow a physical activity program according to the General Physical Activity Guidelines |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age above 65
- Able to undergo graded stress exam
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| Physical ActivityPhysical activity either by individualized program or general guidelines | Behavioural | General Physical Activity Guidelines, Individualized Program |
Primary outcome
Aerobic Fitness
Time frame: One year
Aerobic fitness will be measured with a graded stress exam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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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 Physical Activity in people with Aging, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 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 3 Jun 2013. 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 Israel. 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. 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?
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?
Aerobic Fitness (time frame: One year). 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 3 Jun 2013.