- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218905
Normative Values and Forming Regression Equations for One Minute Sit to Stand Test in Healthy Normal Indian Population (1minSTS)
August 29, 2014 updated by: Baskaran Chandrasekaran
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
196
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tamilnadu
-
Coimbatore, Tamilnadu, India, 641004
- PSG Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both genders
- 30 - 80 years old
- Hospital staffs, relatives of patients volunteering the test
- Willing to give consent for the test
Exclusion Criteria:
- Chronic cardiovascular and pulmonary diseases
- On anticoagulants
- Cancer undergoing chemo, radiotherapy
- recent orthopaedic ailments (Osteoarthritis, Rheumatoid arthritis, surgeries less than 3 months)
- Balance impairments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sit to stand test
One minute sit to stand in 40 inches armless chair.
Fatigue, breathlessness and failure to maintain tempo will lead to decease the test
|
Subjects will be asked to sit to stand in 40 inches chair for 60 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of repetitions of sit ups within 60 seconds
Time Frame: baseline, 1.5 minutes
|
baseline, 1.5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
heart rate recovery (in seconds)
Time Frame: 1 minute
|
1 minute
|
blood pressure (mmHg)
Time Frame: baseline, 1 minute
|
baseline, 1 minute
|
saturation (%)
Time Frame: baseline, 0.5 minute, 1 minute
|
baseline, 0.5 minute, 1 minute
|
Heart rate (beats/ min)
Time Frame: baseline, 0.5 minute, 1 minute
|
baseline, 0.5 minute, 1 minute
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric variables
Time Frame: Baseline
|
Age, height, weight of the volunteers
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: RM PL Ramanathan, MD DM, PSG Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 12, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
September 1, 2014
Last Update Submitted That Met QC Criteria
August 29, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13/311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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