| CTRI Number |
CTRI/2025/08/093890 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study on Night Shift Office Workers: One Long Session vs. Many Short Sessions of Pedaling on a Small Cycle While Sitting at Work and Their Effect on Mood, Energy, and Focus |
|
Scientific Title of Study
|
Comparing the effects of Single Versus Multiple Bouts of Under-Desk Cycling on Mood, Vigor, and Cognitive Function in Night Shift Office Workers: A Pilot Crossover Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
IMMANUEL CARTER B |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9003589012 |
| Fax |
|
| Email |
immanuel.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baskaran Chandrasekaran |
| Designation |
Assistant Professor-Selection Grade, HOD –In Charge |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7639280751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baskaran Chandrasekaran |
| Designation |
Assistant Professor-Selection Grade, HOD –In Charge |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Exercise and Sports Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7639280751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Baskaran |
CENTER FOR SPORTS SCIENCES AND MEDICINE RESEARCH |
-5 FLOOR, DEPARTMENT OF EXERCISE AND SPORTS SCIENCE, MANIPAL, UDUPI
Udupi
KARNATAKA |
7639280751
baskaran.c@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants free of non communicable diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioral intervention - Under desk cycling (Multiple bout)
|
The volunteers will undergo 6 hours of sitting with under-desk cycling for 5 minutes at the beginning of each hour during the intervention. |
| Comparator Agent |
Behavioral intervention - Under desk cycling ( Single bout) |
The volunteers will go for 6 hours of sitting, performing under-desk cycling for 30 minutes prior to their work |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The participants will include male and female adults between the ages of 25 and 50 years who work night shifts in office settings. Additionally, participants must report engaging in less than 150 minutes per week of moderate to vigorous physical activity. |
|
| ExclusionCriteria |
| Details |
People will be excluded if they have any known medical conditions or cognitive disorders that could affect the study, are taking medications that influence mood, cognition, or metabolism, are smokers, consume more than three caffeinated drinks per day, or are pregnant or lactating. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mood |
o, 3rd and 6th hour o the trial day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vigor |
o, 3rd and 6th hour of the trial day |
| Executive function |
o, 3rd and 6th hour of the trial day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
11/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This pilot crossover randomized controlled trial aims to compare the effects of single versus multiple bouts of under-desk cycling on mood, vigor, and cognitive function among night shift office workers. Twenty-eight participants aged 25 to 50 years who work night shifts and engage in less than 150 minutes of physical activity per week will be included. Participants will be randomized to either a single 30-minute session before the shift or six 5-minute sessions spaced hourly during the shift. Mood and vigor will be assessed using the Visual Analogue Scale, and cognitive function will be measured using the Eriksen Flanker Task and the N-Back test. After a one-week washout period, participants will cross over to the alternate condition. Data will be analyzed using a linear mixed model. The study aims to determine which intervention is more effective in enhancing well-being and cognitive performance during night shifts, contributing to workplace health strategies for reducing sedentary behavior and improving employee outcomes. |