| CTRI Number |
CTRI/2025/10/096019 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Exercise Program to Reduce Anxiety and Depression and Improve Quality of life among Elderly in Guntur Old Age Homes. |
|
Scientific Title of Study
|
A study to Evaluate the Effectiveness of Physical Activity Program (PAP) on Mental health (Anxiety, Depression) and Quality of
life among Elderly residing in selected old age homes of Guntur District. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Dinesh Kumar |
| Designation |
Msc Nursing Student |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
103, College of Nursing, AIIMS Mangalagiri, Guntur (A.P.) – 522503.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8955353036 |
| Fax |
|
| Email |
dineshkadela123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan P. |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room No. 408, College of Nursing, AIIMS Mangalagiri, Guntur District – 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7988410148 |
| Fax |
|
| Email |
vasans85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Dinesh Kumar |
| Designation |
Msc Nursing Student |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
103, College of Nursing, AIIMS Mangalagiri, Guntur (A.P.) – 522503.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8955353036 |
| Fax |
|
| Email |
dineshkadela123@gmail.com |
|
|
Source of Monetary or Material Support
|
| 103, College of Nursing, AIIMS Mangalagiri, Guntur (A.P.) – 522503 |
|
|
Primary Sponsor
|
| Name |
Mr Dinesh Kumar |
| Address |
103,College Of Nursing ,AIIMS MANGALAGIRI GUNTUR (A.P.)522503. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Mr Dinesh Kumar |
AIIMS Mangalagiri |
103, College of Nursing, AIIMS Mangalagiri, Guntur (A.P.) – 522503.
Guntur
ANDHRA PRADESH |
8955353036
dineshkadela123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human Volunteers in the study are Elderly people residing in selected old age homes of Guntur district |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No specific intervention. |
Control group will not be provided any intervention. |
| Intervention |
Physical activity program will be administered to the experimental group over 2 weeks. |
1. Comprehensive Education with Startup Session (Day 1)
General information and brief psychoeducation
Warm up
Free walking
Cooling down (sitting and deep breathing)
2. Moderate Aerobic Physical Activity Session (Day 2 and Day 3)
Warm up
Free walking
Aerobic exercise (brisk walking, dancing, fun activity such as musical chair)
Cooling down (sitting and deep breathing)
3. Multicomponent Activities Session for Strengthening and Balance (Day 4, Day 5 and Day 6)
Warm up
Free walking
Muscle strengthening activities (wall push-ups, seated leg lifts, gentle squats, ball pass)
Cooling down (sitting and deep breathing)
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Having a score of five or more in the Geriatric Depression Scale (GDS), and more than zero on the Geriatric Anxiety Scale (GAS).
2.Residing in selected old age homes.
3.Both genders aged sixty years and above.
4.Willing to participate in the study.
5.Alert, oriented, and able to comprehend and respond.
6.Able to speak and understand either Telugu or English.
7.Able to move without walking aids or any physical assistance |
|
| ExclusionCriteria |
| Details |
1.With temporary or permanent disability.
2.Having serious medical or neurological conditions as per records that limit physical ability (examples include heart disease, drowsiness, etc.).
3.Not available during the study period.
4.Already engaged in regular physical activity for at least one hundred and fifty minutes per week.
5.Receiving any psychotherapy from a mental health professional as per records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety ,depression and quality of life . |
Baseline day 30,Day 45 . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Satisfaction regarding Physical Activity Program (PAP) in intervention group. |
Baseline day 30,Day 45 . |
| |
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "67"
Final Enrollment numbers achieved (India)="67" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
15/03/2026 |
| 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)
|
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)
|
The proportion of elderly individuals in the population has been steadily rising since the year nineteen fifty one. It was projected to reach ten point one percent in the year twenty twenty one and is expected to increase to thirteen point one percent by the year twenty thirty one. With greater life expectancy, older adults are increasingly vulnerable to various health concerns such as physical illnesses, dependency, loneliness, social isolation, and mental health issues like anxiety, depression, and reduced quality of life. According to the World Health Organization, older adults should engage in at least one hundred and fifty minutes of physical activity per week, ideally in sessions lasting no less than ten minutes. Based on this recommendation and supporting research, the present study titled A Study to Evaluate the Effectiveness of a Physical Activity Program on Mental Health Anxiety and Depression and Quality of Life among the Elderly Residing in Selected Old Age Homes of Guntur District aims to implement a structured physical activity program to improve mental well-being and quality of life among the elderly. A quantitative research approach with a quasi experimental non equivalent control group pretest post test design will be used. Elderly aged sixty years and above, residing in selected old age homes of Guntur, medically stable, able to communicate in Telugu or English, and willing to participate will be included. Based on power analysis the required sample size for each group is thirty five. Convenience sampling will be used. Standardized tools such as Geriatric Anxiety Scale, Geriatric Depression Scale, and WHO Quality of Life Brief Questionnaire will be used to assess baseline mental health and quality of life in both experimental and control groups. The experimental group will receive a two week intervention that includes an initial educational session, moderate intensity aerobic exercises, and multi component activities focusing on strength and balance. Follow up assessments will be conducted on day thirty and day forty five after the intervention to evaluate changes in anxiety, depression, and quality of life. |