| CTRI Number |
CTRI/2026/03/106262 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on the relationship between sleep quality,tiredness,mental health,and daily physical ability in people with bronchial asthma |
|
Scientific Title of Study
|
Association between Sleep quality with Fatigue, Anxiety, Depression and Functional capacity in individuals with Intrinsic Bronchial Asthma – A cross-sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suvetha P |
| Designation |
MPT STUDENT |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
Sf No 259 & 267,Kalapatti post Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
08012190906 |
| Fax |
|
| Email |
suvetha1472001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs AP Kalpana |
| Designation |
Professor |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
Department of Physiotherapy,
Room no. 001
Sf No 259 & 267,Kalapatti post Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9842090310 |
| Fax |
|
| Email |
apkalpanapt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs AP Kalpana |
| Designation |
Professor |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
Department of Physiotherapy,
Room no. 001
Sf No 259 & 267,Kalapatti post Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9842090310 |
| Fax |
|
| Email |
apkalpanapt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
Sf no 259 267 kalapatti post Coimbatore 641048
Tamil nadu, India |
| Type of Sponsor |
Private medical college |
|
|
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 Kandavel GS |
KMCH Institution of health sciences and research |
Department of Pulmonology,
Room no. 03 , 2nd floor
99 avinashi road Coimbatore 641014
Coimbatore
TAMIL NADU |
8973405312
kissankandavel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Commitee KMCH Institute of allied Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals diagnosed with Intrinsic bronchial asthma
2. Individuals having FEV1 range 30 – 49%
3. Participants who are willing to participate in the study and provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Individuals with unstable cardiac conditions such as myocardial infraction.
2. Other respiratory disease (COPD, Lung cancer)
3. Acute pneumonia
4. Any other neurological and orthopaedics disorders
• Individuals with cognitive impairment.
• Known cases of Psychotic disturbances
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sleep Quality- Pittsburgh quality of sleep index
2.Fatigue-Checklist individual strength index
3.Anxiety and depression- Hospital anxiety and depression scale
4.Functional capacity-6MWT
|
Measured at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Bronchial asthma is a common chronic respiratory disease that affects the physical and psychological health of individuals. Many patients with asthma experience poor sleep quality due to nocturnal symptoms such as breathlessness, coughing, and wheezing. Poor sleep may further contribute to increased fatigue, anxiety, depression, and reduced functional capacity in daily activities. However, the relationship between sleep quality and these factors is not well explored in individuals with bronchial asthma. Therefore, this study aims to determine the association between sleep quality with fatigue, anxiety, depression, and functional capacity in individuals with bronchial asthma. This cross sectional study will help to understand the impact of sleep disturbances on both physical and psychological outcomes in asthma patients and may help in improving comprehensive management strategies. |