| CTRI Number |
CTRI/2025/03/081501 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
How Recreational Activities and Physiotherapy Improve Memory and Mood in Older Adults A Quasi Experimental Study |
|
Scientific Title of Study
|
Added Effects Of Recreational Activates Along With Conventional Physiotherapy On Cognitive Function And Emotional Wellbeing in Elderly A Quasi Experimental |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Kale |
| Designation |
Intern |
| Affiliation |
Dr D Y Patil College Of Physiotherapy |
| Address |
Room number 3 3rd floor cardilogy department Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune
Pune MAHARASHTRA 411018 India |
| Phone |
7040051765 |
| Fax |
|
| Email |
nikhil.kale754@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mayuri Shah |
| Designation |
Faculty |
| Affiliation |
Dr D Y Patil College Of Physiotherapy |
| Address |
Room number 3 3rd floor cardilogy department Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune
Pune MAHARASHTRA 411018 India |
| Phone |
8087861628 |
| Fax |
|
| Email |
mayuri.shah@dpu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Mayuri Shah |
| Designation |
Faculty |
| Affiliation |
Dr D Y Patil College Of Physiotherapy |
| Address |
Room number 3 3rd floor cardilogy department Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune
MAHARASHTRA 411018 India |
| Phone |
8087861628 |
| Fax |
|
| Email |
mayuri.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College Of Physiotherapy |
| Address |
Room number 3 3rd floor cardiology department Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune 411018 |
| 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 Nikhil Kale |
Dr D Y Patil College Of Physiotherapy |
Room number 3 3rd floor cardiology department Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune Pune MAHARASHTRA |
7040051765
nikhil.kale754@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Sub Ethics Committee Dr D Y Patil Vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Recreational Activities To Improve The Cognition And Emotional Wellbeing In An Elderly A Quasi Experimental Study |
Recreational Activities Protocol –
Each game will be played 2 Times per session / 3 times a Week For 6 Weeks
Tangram Puzzle
The Tangram puzzle game made up of seven flat pieces known as Tans. These pieces come in various shapes, including squares, triangles, and parallelograms, which has to arrange all the pieces into some shapes or figures.
Instructions –
“Individual has to sit on the chair and the puzzle game will be kept on the tableâ€
“The therapist will sit in front of the individual and the individual has asked to make the shapes or figures from the given tans.â€
The individual can make any shape or figures but it has to be made within the time.
Time – 5Mins
Cup Stacking
Cup Stacking, or Sport Stacking, is a Dynamic and Thrilling Activity that Challenges Participants to Rapidly Assemble Plastic Cups.
The cup stacking game played using the plastic cups which has to be placed on the table.
Instructions –
“Assemble the cups as fast as u canâ€
“Again disassemble itâ€
Time – 5Mins
Peg Board
Pegboard tool is good for elderly individuals which provide a number of neurological benefits as they encourage the use of multiple brain regions and neural pathways. They provide a holistic approach to cognitive and physical health by engaging both the brain through mental engagement.
The pegboard has to be kept on the table the individual and therapist will sit on the chair.
Instructions –
“Hold the peg in one hand and place it in the specific holes.
“Place all the pegs in holes and complete the task in the given time periodâ€
Time – 5Mins
Jenga
Jenga is a fun and easy tabletop game which improves strategy, skill, and focus. The game starts with a tower made of wooden blocks, and individuals asked to remove one block from anywhere below the highest completed layer, then carefully placing it on top. The challenge is to keep the tower standing as it grows taller, without knocking it over. As the game continues, the tower becomes wobblier. It’s a great way to have fun while also sharpening your coordination, concentration, and problem-solving skills.
Instructions –
“Assemble the blocks and make the towerâ€
“Once all the blocks are assembled remove one block from top or bottomâ€
“Make sure that the tower should not crumbleâ€
“If the tower gets crumbled then the tower has to be re-assembled againâ€
Time – 5Mins
|
| Comparator Agent |
Recreational Activities To Improve The Cognition And Emotional Wellbeing In An Elderly A Quasi Experimental Study |
Recreational Activities Protocol –
Each game will be played 2 Times per session / 3 times a Week For 6 Weeks
Tangram Puzzle
The Tangram puzzle game made up of seven flat pieces known as Tans. These pieces come in various shapes, including squares, triangles, and parallelograms, which has to arrange all the pieces into some shapes or figures.
Instructions –
“Individual has to sit on the chair and the puzzle game will be kept on the tableâ€
“The therapist will sit in front of the individual and the individual has asked to make the shapes or figures from the given tans.â€
The individual can make any shape or figures but it has to be made within the time.
Time – 5Mins
Cup Stacking
Cup Stacking, or Sport Stacking, is a Dynamic and Thrilling Activity that Challenges Participants to Rapidly Assemble Plastic Cups.
The cup stacking game played using the plastic cups which has to be placed on the table.
Instructions –
“Assemble the cups as fast as u canâ€
“Again disassemble itâ€
Time – 5Mins
Peg Board
Pegboard tool is good for elderly individuals which provide a number of neurological benefits as they encourage the use of multiple brain regions and neural pathways. They provide a holistic approach to cognitive and physical health by engaging both the brain through mental engagement.
The pegboard has to be kept on the table the individual and therapist will sit on the chair.
Instructions –
“Hold the peg in one hand and place it in the specific holes.
“Place all the pegs in holes and complete the task in the given time periodâ€
Time – 5Mins
Jenga
Jenga is a fun and easy tabletop game which improves strategy, skill, and focus. The game starts with a tower made of wooden blocks, and individuals asked to remove one block from anywhere below the highest completed layer, then carefully placing it on top. The challenge is to keep the tower standing as it grows taller, without knocking it over. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Elderly aged 60-70 years.
Score of 10-25 on MOCA. (mild to moderate cognition affection)
Score of 10-30 on GDS. (mild to moderate affection of emotional wellbeing)
Both genders
Willing Participants
|
|
| ExclusionCriteria |
| Details |
Participants already undergoing any form of treatment for cognition depletion and emotional wellbeing affection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Montreal Cognitive Assessment (MOCA)
Geriatric Depression Scale (GDS) |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Montreal Cognitive Assessment (MOCA)
|
6 Weeks |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| Date of Study Completion (India) |
24/03/2025 |
| Date of First Enrollment (Global) |
24/03/2025 |
| Date of Study Completion (Global) |
24/03/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="3" 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
|
The global demographic shift toward an aging population has heightened the focus on age-related health challenges, particularly cognitive decline which affects essential daily functions such as memory, attention and emotional well-being that can affect the quality of life of seniors [1]. Aging is defined as natural and gradual process of biological, psychological, and social changes that occur in living organisms over time. Biologically, aging involves changes at the cellular and molecular levels, including DNA damage, decreased cell division, and the buildup of cellular waste products [2]. These alterations lead to the gradual deterioration of tissues and organs, resulting in a decline in overall health and vitality. Psychologically, aging may bring about changes in cognitive functions, including memory, attention, and problem-solving skills, along with alterations in emotional states [3]. On the basis of anatomical changes at neurological levels in elderly it involves the alterations in the brain, spinal cord. In brain it is seen that brain atrophy occurs which includes cortical thinning. The cerebral cortex, which governs higher cognitive functions like reasoning, memory, and language, gradually thins with age. This thinning is especially noticeable in the prefrontal cortex, a region crucial for executive functions, and the hippocampus, which is vital for memory formation [4]. Another major changes in being noticed as the person ages is the number of neurons starts decreasing Aging-related structural changes to neurons include a decrease in the number and length of dendrites, loss of dendritic spines, a decrease in the number of axons, an increase in axons with segmental demyelination, and a significant loss of synapses. Synaptic loss is a key structural marker of aging in the nervous system [5]. Neuron loss is not uniform across the brain, certain regions of the brain experience significant reductions in the number of neurons. For example, the hippocampus and the frontal lobes show notable neuron loss, contributing to memory decline and changes in decision-making abilities which is majorly seen in elderly population [6]. On neuro-chemical levels the neurotransmitter system shows significant decrease of the neuro-chemicals like dopamine and serotonin & acetylcholine [7]. Dopamine is a neurotransmitter for movement motivation and reward processing, the reduction of the same results in decreased motivation to perform any activities of daily living [8]. Another neurotransmitter which is serotonin & acetylcholine which contributes mood regulation and memory also starts to decline with age which ultimately leads to mood disorders and cognitive decline [9,10]. However, few approaches which is being constantly in use i.e. pharmacological treatment. Evidence of pharmacological interventions for cognitive impairment in older adults the available medications Donepezil, Galantamine, Rivastigmine, Intranasal Insulin, Cerebrolysin and Acetylsalicylic Acid, Metformin and Memantine [11]. Non-Pharmacological Approach - Many of the pharmacological drugs are available but for the non-pharmacological treatment or intervention the physiotherapy is the cornerstone of the non- Pharmacological treatment which mainly focuses on improving physical function, mobility, cognition and overall health. It constitutes the exercises related to the balance, co-ordination, mobility [12]. Conventional therapy is the major non pharmacological treatment but sometimes it shows that the only physiotherapy is stressful to the patients and many a times patients refuses to complete the physiotherapy sessions. Thus, to make it more interactive and playful there’s another approach which is being used along with conventional physiotherapy is recreational games which are quite interactive to the patients and the population does enjoy the treatment process. Recreational activities are gaining increasing recognition for their significant role in enhancing cognitive function and emotional well-being among the elderly [13]. These activities, which include a variety of mentally stimulating and socially engaging exercises like music therapy, art therapy, and group games like puzzle games [14], are not only enjoyable but also crucial for promoting mental health and cognitive resilience in older adults. Studies have shown that such activities can help delay the onset of cognitive decline, improve memory, and reduce symptoms of depression and anxiety. These activities play a vital role in combating loneliness and social isolation, which are common contributors to emotional distress in the elderly. |