ActivityPhase 1/2NCT02259673
Effects of Fun Physical Activity on the Interest to Daily Physical Activity and Sarcopenia of Elderly People
A Phase 1/2 study testing Fun exercise in people with Activity, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
In this research, the elderly living in nursing homes were selected in two group control and intervention. Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc). Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Activity
- What is being tested?
- Fun exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIran
- Study dates
- Sep 2014to Jun 2015
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age more than 60 year
Who cannot join
- absence more than 3 session training
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashhad University Medical of siences
Mashhad
zohre najafi, Msc student, 09153819224, najafiz2@mums.ac.ir
About this study
Official title: Mashhad University Medical of Sciences
In this research, the elderly living in nursing homes were selected in two group control and intervention.
Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).
Read the detailed description
Have of a healthy life with minimal complications in this period. Most important issue in improving the health and quality of life of the elderly is maintain their independence in physical activity. World Health Organization (WHO) is believed that, the first indicator of the health of a society is physical activity of the society.
The studies show that sarcopenia leads to a decrease in the function and increase of disability 2/1 male and 3/1 are older women. sarcopenia leads to some perturbation such as, movement disorders, impaired balance, the incidence of inflammatory disease and dementia. In this reserch, the elderly living in nursing homes were selected in two group control and intervention.
Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises.
(including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).
- Conditions
- Activity
- Being tested
- Fun exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fun exerciseOther
Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc)
fun exerciseOther
Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises
(including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc)
| Study group | Role | What they receive |
|---|---|---|
| Fun exercise | Experimental | effect of fun physical exercise on sarcopenia Receives: Other: Fun exercise |
| fun exercise | Experimental | effect of fun physical exercise on interest in exercise Receives: Other: Fun exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
interest of daily physical activity
including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc that will be measured with Exercise Dependence Scale-21 Manual(EDS)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ActivityStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Grudzen, Corita, M.D., MSHS
- Responsible party
- Principal investigator, rajabpoor, Mashhad University of Medical Sciences
- Investigators
- Mohammad rajabpoor, Msc student, Study director, Msc student, Mashhad University Medical of Siences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259673
- Sponsor's protocol ID
- 920788
- Status last verified
- Apr 2015
- First submitted
- 29 Sep 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Canga L, Gorelik G, Sterin-Borda L. Diabetes alters the reactivity of myocardium to a thromboxane analogue. Can J Physiol Pharmacol. 1987 Apr;65(4):499-503. doi: 10.1139/y87-085.
PubMed 2886201
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mashhad University Medical of Sciences
- ClinicalTrials.gov ID
- NCT02259673
- Acronym / sponsor ID
- 920788
- Conditions
- Activity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Grudzen, Corita, M.D., MSHS
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 Oct 2014 (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.
In this research, the elderly living in nursing homes were selected in two group control and intervention.
Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).
Detailed description
Have of a healthy life with minimal complications in this period. Most important issue in improving the health and quality of life of the elderly is maintain their independence in physical activity. World Health Organization (WHO) is believed that, the first indicator of the health of a society is physical activity of the society.
The studies show that sarcopenia leads to a decrease in the function and increase of disability 2/1 male and 3/1 are older women. sarcopenia leads to some perturbation such as, movement disorders, impaired balance, the incidence of inflammatory disease and dementia. In this reserch, the elderly living in nursing homes were selected in two group control and intervention.
Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises.
(including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fun exercise | Experimental | Other: Fun exerciseeffect of fun physical exercise on sarcopenia |
| fun exercise | Experimental | Other: Fun exerciseeffect of fun physical exercise on interest in exercise |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age more than 60 year
Key exclusion criteria (1 listed)
- absence more than 3 session training
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 |
|---|---|---|
| Fun exerciseIntervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc) | Other | Fun exercise, fun exercise |
| fun exerciseIntervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc) | Other | Fun exercise, fun exercise |
Primary outcome
interest of daily physical activity
Time frame: one month
including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc that will be measured with Exercise Dependence Scale-21 Manual(EDS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Results publication: PubMed 2886201Canga L, Gorelik G, Sterin-Borda L. Diabetes alters the reactivity of myocardium to a thromboxane analogue. Can J Physiol Pharmacol. 1987 Apr;65(4):499-503. doi: 10.1139/y87-085.
- article cited this sitLink provided by the sponsor.
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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.
Mohammad rajabpoor, Msc student study director
Msc student, Mashhad University Medical of Siences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fun exercise in people with Activity, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 1 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 8 Apr 2015. 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 Iran. 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.
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?
Contact zohre najafi, Msc student (09153819224, najafiz2@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interest of daily physical activity (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02259673, which also lists 1 linked publication.
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 8 Apr 2015.