Normative Values and Forming Regression Equations for One Minute Sit to Stand Test in Healthy Normal Indian Population

Human Healthy Volunteers Clinical Trial

— 1minSTS  

Official title:

Phase 0 Study of Reference Values for One Minute Sit to Stand Test in Healthy Indian Population - a Cross Sectional Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02218905
• Other study ID #: 13/311
• Status: Enrolling by invitation
• Phase: Phase 0
• First received: August 12, 2014
• Last updated: August 29, 2014
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: PSG Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical 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. This may partially define the ability of functional capacity and quadriceps ability.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 196
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Human Healthy Volunteers

Intervention

Behavioral:
• Sit to stand test
Subjects will be asked to sit to stand in 40 inches chair for 60 seconds.

Locations

Country	Name	City	State
India	PSG Hospitals	Coimbatore	Tamilnadu

Sponsors (2)

Lead Sponsor	Collaborator
Baskaran Chandrasekaran	PSG Hospitals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric variables	Age, height, weight of the volunteers	Baseline	No
Primary	Number of repetitions of sit ups within 60 seconds		baseline, 1.5 minutes	No
Secondary	heart rate recovery (in seconds)		1 minute	No
Secondary	blood pressure (mmHg)		baseline, 1 minute	No
Secondary	saturation (%)		baseline, 0.5 minute, 1 minute	No
Secondary	Heart rate (beats/ min)		baseline, 0.5 minute, 1 minute	No