Human Healthy VolunteersEarly Phase 11minSTSNCT02218905
Normative Values and Forming Regression Equations for One Minute Sit to Stand Test in Healthy Normal Indian Population
A Early Phase 1 study testing Sit to stand test in people with Human Healthy Volunteers, run by Baskaran Chandrasekaran at 1 site in India.
Trial summary
This study is to find relation between number of repetitions the volunteer able to sit and stand in an armless chair and their age, height, weight and gender. The investigators hypothesis there is a moderate relation between anthropometric characteristics and number of situps. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Healthy Volunteers
- What is being tested?
- Sit to stand test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2014to Dec 2015
- Phase
- Early Phase 1
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both genders
- 30 - 80 years old
- Hospital staffs, relatives of patients volunteering the test
- Willing to give consent for the test
Who cannot join
- Chronic cardiovascular and pulmonary diseases
- On anticoagulants
- Cancer undergoing chemo, radiotherapy
- recent orthopaedic ailments (Osteoarthritis, Rheumatoid arthritis, surgeries less than 3 months)
- Balance impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 0 Study of Reference Values for One Minute Sit to Stand Test in Healthy Indian Population - a Cross Sectional Study
This study is to find relation between number of repetitions the volunteer able to sit and stand in an armless chair and their age, height, weight and gender. The investigators hypothesis there is a moderate relation between anthropometric characteristics and number of situps. This may partially define the ability of functional capacity and quadriceps ability.
Read the detailed description
Sit to stand is gaining importance as a functional capacity measurement tool in modern chronic diseases arena. Bu the reference values for normative population is not available. Hence the present study aimed at finding relation between the anthropometric variables (age, height, weight) and number of sit to stand repetitions. The volunteers will be asked to sit to stand in an arm less chair of 40 inches height. The number of repetition will be correlated and regression equations will be sought out relating number of repetitions and anthropometric variables through best fit regression equations
- Conditions
- Human Healthy Volunteers
- Being tested
- Sit to stand test
- Keywords
- Correlation, Sit to stand repetitions, Anthropometric variables, Age, Height, weight, Gender, Regression
- Medical subject headings
- Body Weight, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit to stand testBehavioural
Subjects will be asked to sit to stand in 40 inches chair for 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Sit to stand test | Experimental | One minute sit to stand in 40 inches armless chair. Fatigue, breathlessness and failure to maintain tempo will lead to decease the test Receives: Behavioral: Sit to stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of repetitions of sit ups within 60 seconds
Measured: baseline, 1.5 minutes
Secondary outcomes (4)
heart rate recovery (in seconds)
Measured: 1 minute
blood pressure (mmHg)
Measured: baseline, 1 minute
saturation (%)
Measured: baseline, 0.5 minute, 1 minute
Heart rate (beats/ min)
Measured: baseline, 0.5 minute, 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Healthy VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskaran Chandrasekaran
- Sponsor type
- University, hospital or other
- Collaborators
- PSG Hospitals
- Responsible party
- Sponsor-investigator, Baskaran Chandrasekaran, PSG Hospitals
- Investigators
- RM PL Ramanathan, MD DM, Principal investigator, PSG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218905
- Sponsor's protocol ID
- 13/311
- Acronym
- 1minSTS
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Study of Reference Values for One Minute Sit to Stand Test in Healthy Indian Population - a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02218905
- Acronym / sponsor ID
- 1minSTS / 13/311
- Conditions
- Human Healthy Volunteers
- Keywords
- Correlation, Sit to stand repetitions, Anthropometric variables, Age, Height, weight, Gender, Regression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Baskaran ChandrasekaranUniversity, hospital or other
- Collaborators
- PSG Hospitals
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Aug 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.
This study is to find relation between number of repetitions the volunteer able to sit and stand in an armless chair and their age, height, weight and gender. The investigators hypothesis there is a moderate relation between anthropometric characteristics and number of situps. This may partially define the ability of functional capacity and quadriceps ability.
Detailed description
Sit to stand is gaining importance as a functional capacity measurement tool in modern chronic diseases arena. Bu the reference values for normative population is not available. Hence the present study aimed at finding relation between the anthropometric variables (age, height, weight) and number of sit to stand repetitions. The volunteers will be asked to sit to stand in an arm less chair of 40 inches height. The number of repetition will be correlated and regression equations will be sought out relating number of repetitions and anthropometric variables through best fit regression equations
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sit to stand test | Experimental | Behavioral: Sit to stand testOne minute sit to stand in 40 inches armless chair. Fatigue, breathlessness and failure to maintain tempo will lead to decease the test |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders
- 30 - 80 years old
- Hospital staffs, relatives of patients volunteering the test
- Willing to give consent for the test
Key exclusion criteria (5 listed)
- Chronic cardiovascular and pulmonary diseases
- On anticoagulants
- Cancer undergoing chemo, radiotherapy
- recent orthopaedic ailments (Osteoarthritis, Rheumatoid arthritis, surgeries less than 3 months)
- Balance impairments
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 |
|---|---|---|
| Sit to stand testSubjects will be asked to sit to stand in 40 inches chair for 60 seconds. | Behavioural | Sit to stand test |
Primary outcome
Number of repetitions of sit ups within 60 seconds
Time frame: baseline, 1.5 minutes
4 secondary outcomes
heart rate recovery (in seconds)
Time frame: 1 minute
blood pressure (mmHg)
Time frame: baseline, 1 minute
saturation (%)
Time frame: baseline, 0.5 minute, 1 minute
Heart rate (beats/ min)
Time frame: baseline, 0.5 minute, 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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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.
RM PL Ramanathan, MD DM principal investigator
PSG Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sit to stand test in people with Human Healthy Volunteers, run by Baskaran Chandrasekaran at 1 site in India.
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 5 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 1 Sep 2014. 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 India. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of repetitions of sit ups within 60 seconds (time frame: baseline, 1.5 minutes). 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 1 Sep 2014.