| CTRI Number |
CTRI/2026/03/106601 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Breathing Exercise Versus Mental Imagery to Improve Sleep and Reduce Fatigue in Older Adults with Sleep Problems |
|
Scientific Title of Study
|
Effect of Buteyko breathing exercise versus Mental imagery technique on fatigue, sleep and quality of life in elderly population with sleep disturbance A Randomized controlled 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 |
Vinayak Tukare |
| Designation |
PG Student |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9731629818 |
| Fax |
|
| Email |
vinayaktukare2043@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Vice Principal and Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Kanabur |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijayalaxmi Kanabur |
KAHER Institute Of Physiotherapy |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, CBR department OPD no.39, Nehru Nagar,Belgavi Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA |
8867480565
vvkdeeksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee of KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep Disturbance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko breathing exercise |
The Buteyko technique involves nasal inhalation and exhalation with the mouth closed, followed by a voluntary breath-hold until the urge to breathe is felt. Each session consists of 10–15 repetitions with a rest period of 30 seconds to 2 minutes between cycles. The intervention will be administered once daily, 5 days per week for 4 weeks. |
| Comparator Agent |
Conventional breathing exercise |
The Conventional Breathing Exercise program includes Diaphragmatic Breathing, Pursed Lip Breathing, Segmental Breathing, and Thoracic Expansion exercises. In diaphragmatic breathing, participants will sit with slight trunk flexion and receive tactile feedback by placing one hand over the upper abdomen and the other over the chest. They will be instructed to inhale slowly and deeply through the nose without using accessory muscles and exhale slowly through the mouth, focusing on abdominal and chest expansion. Each exercise will be performed for 10–15 repetitions per session, once daily, 5 days per week for 4 weeks. |
| Comparator Agent |
Mental imagery technique |
The Mental Imagery Technique consists of a guided relaxation session conducted in a comfortable supine position with head and neck supported. Participants are instructed to perform slow, deep breathing while progressively relaxing different body parts. They are guided to release physical tension with each exhalation and focus on a calming nighttime visualization scene (e.g., lying under the stars in a peaceful natural environment). Participants are encouraged to ignore distracting thoughts and gently return their attention to breathing and imagery. The session promotes physical relaxation, mental calmness, and preparation for sleep. 10–15 repetitions per session
Once daily 5 days per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of any gender aged 60 to 80 years with a score more than 5 on PQSI ,Individuals who can comprehend given commands. |
|
| ExclusionCriteria |
| Details |
Individuals who are known case of sever and uncontrolled angina, myocardial infarction,
epilepsy and glaucoma, Individuals who do not wish to participate in this study voluntarily. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh sleep quality index, Fatigue severity scale and Brief older peoples quality of life questionnaire. |
Baseline , After 10 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
23/03/2026 |
| 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="1"
Months="0"
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
|
Prior to commencement, ethical clearance will be obtained from the Institutional Ethics Committee. The study will be conducted in accordance with the Declaration of Helsinki and ICMR guidelines. CTRI registration will be completed after ethical approval. Participants will be recruited from Belagavi city through flyers and screened based on inclusion and exclusion criteria. The purpose and procedure of the study will be explained, and written informed consent will be obtained. Demographic details will be recorded. Eligible participants will be randomly allocated into three groups: Group A Buteyko breathing exercise and conventional breathing exercise, Group B Mental imagery technique and conventional breathing exercise, and Group C Conventional breathing exercise. Interventions will be administered by trained physiotherapists. Pre-assessment will be conducted at baseline and post-assessment after 4 weeks. |