CTRI Number |
CTRI/2018/07/014878 [Registered on: 16/07/2018] Trial Registered Prospectively |
Last Modified On: |
11/07/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Is calf muscle strength a predictor of risk of falls in elderly? |
Scientific Title of Study
|
Can Plantar Flexor strength predict risk of falls in elderly? |
Trial Acronym |
CPFSPROFIE |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Payal Shetkar |
Designation |
PG student |
Affiliation |
Sancheti Institute College of Physiotherapy |
Address |
Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy, 1st floor,
11/12 Thube park, Shivajinagar, Pune 411005
Pune MAHARASHTRA 411005 India |
Phone |
9673295038 |
Fax |
|
Email |
shetkarpayal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrGajanan Bhalerao |
Designation |
Professor |
Affiliation |
Sancheti Institute College of Physiotherapy |
Address |
Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy,1st floor, 11/12 Thube park, Shivajinagar, Pune 411005
Pune MAHARASHTRA 411005 India |
Phone |
9822623701 |
Fax |
|
Email |
gajanan_bhalerao@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
DrGajanan Bhalerao |
Designation |
Professor |
Affiliation |
Sancheti Institute College of Physiotherapy |
Address |
Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy,1st floor, 11/12 Thube park, Shivajinagar, Pune 411005
Pune MAHARASHTRA 411005 India |
Phone |
9822623701 |
Fax |
|
Email |
gajanan_bhalerao@yahoo.com |
|
Source of Monetary or Material Support
|
Payal Shetkar
Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy, 1st floor,
11/12 Thube park, Shivajinagar, Pune 411005
|
|
Primary Sponsor
|
Name |
sancheti institute college of physiotherapy |
Address |
Sancheti Institute College of Physiotheraspy, Sancheti Healthcare academy, Thube Park 1112, Shivajinagar, Pune |
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 |
Payal Shetkar |
Old age home, Community dwelling eldery of pune city |
Pune city Pune MAHARASHTRA |
02028999713
shetkarpayal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board, Sancheti Institute for Orthopaedics and Rehabilitation,Pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Geriatric Individuals between 60 to 80 years |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1.Males and Females in the age group of 60 to 80years.
2.Walking atleast 10 meters.
|
|
ExclusionCriteria |
Details |
1. Any cardiovascular, musculoskeletal involvement severe enough to affect ambulation.
2. Central nervous system pathology.
3. Visual impairment (blindness, cataract causing severe visual challenge wherein basic ADLs are difficult),
4. Auditory impairment (should be able to hear instructions correctly, with or without hearing Aid),
5. Cognitive impairment (MMS < 24)
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Plantar flexor strength: Micro-FET HHD
2. Dorsiflexion ROM: Weight bearing lunge test
3. Case record: Fall risk assessment tool(FRAT)
4. Dynamic balance: TUGT
5. Anthropometric measures: BMI
6. Physical activity level: PASE
|
one time assessment |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
01/08/2018 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
CAN PLANTAR FLEXOR STRENGTH PREDICT FALLS IN THE ELDERLY? Introduction India is the most populous country having over 104 million elderly persons (aged 60 and above) constituting about 8.6% of the total population in India. The old age dependency ratio increased to 14.9% and 13.6% in males and females respectively in 2011(1). One of the main reasons why this huge number becomes dependent is ‘falls’. Falls are one of the major problems in the elderly and hence are considered as one of the “Geriatric giants†Every year accidental falls occur in nearly one-third of those aged more than 60 years, with 10% of these falls resulting in serious injury(2). Loss of balance and falls in the elderly constitute a major problem associated with human suffering as well as high costs for society(3). But, falls that do not lead to injury often begin a downward spiral of fear that leads to inactivity and decreased strength, agility and balance that often results in loss of independence in normal activities of self-care(4). With the growing aging population, the number of falls will likely increase in coming years. Therefore, there it is necessary to develop and implement low cost, time-efficient, exercise intervention programs targeting particular muscle groups in order to increase strength, functional mobility and balance in older adults and, subsequently, to decrease the risk of falls(5). Hence, finding all the variables influencing the risk of falls in the elderly is essential. Ageing is associated with reduced muscle strength(6). The age-related modifications on motor system can be viewed as examples of an inevitable, genetically programmed process that causes both decline and physiological adaptation in neuromuscular function. These modifications, involving the loss of cells, lead to the reduction in complement of motor neurons and muscle fibres, inducing, in turn, the reduction of muscle mass and strength, especially in the lower limbs(7). Amongst the lower limb muscles, the ratio of muscle strength to muscle thickness in the elderly group was significantly lower than that in the young group in plantar flexors (p<0.001), but not in knee extensors(8). The strength of ankle plantar flexors (PF) is related to mobility functions of older adults(9). The ankle PF provides stability for the weight-bearing limb and allows for advancement of the swinging limb in both walking and stair climbing tasks(10, 11). However, when all 4 muscle groups were considered together, only the PF muscle performance (repeated heel-rise ability) showed a significant association with all 3 mobility tasks. The importance of PF muscle performance in lower extremity ambulation activities has been emphasised(9, 10, 11). The PF is also a significant predictor of postural control(9) and balance(12) in community dwelling older persons. The mobility requirements for ankle DF during gait and balance are primarily weight-bearing related(13). There is decrease in ankle joint range of motion with increasing age and this affects balance also(14). Ankle dorsiflexion measured with weight bearing methods resulted in a significant correlations for balance in the older age group(13) Balance is strongly associated with falls in the elderly. The TUG is a simple and inexpensive tool that was developed to screen functional mobility(15). Within research, the use of the TUG has increased over the last few years, and it is recommended by several geriatric societies when screening for risk of falling.(16), (17) Thus considering all these factors, this study aims to form a predictive model with these variables (Plantar flexor strength, Dorsiflexion ROM), wherein contribution of each variable to the risk of fall will be identified and thus can be used in the intervention to delay their risk of falls.
AIM: To find out the contribution of Plantar flexor strength to the risk of falls in the elderly OBJECTIVE: 1. To assess TUG performance and classify the subjects into fallers or non-fallers group depending on their TUG score. 2. To assess Plantar flexor strength, dorsiflexion ROM, Fall risk assessment tool(FRAT), Physical activity scale in elderly (PASE) in the subjects. 3. To find the contribution of plantar flexor strength, dorsiflexion ROM, Fall risk assessment tool(FRAT), Physical activity scale in elderly (PASE) to the risk of fall in the elderly. | Methodology: STUDY DESIGN: Cross-sectional- Analytical study STUDY POPULATION: Community dwelling elderly SAMPLING TECHNIQUE: Quota sampling SAMPLE SIZE: 70 INCLUSION CRITERIA: 1. Males and Females in the age group of 60 to 80years. 2. Walking atleast 10 meters. EXCLUSION CRITERIA: 1. Any cardiovascular, musculoskeletal involvement severe enough to affect ambulation. 2. Central nervous system pathology. 3. Visual impairment (blindness, cataract causing severe visual challenge wherein basic ADLs are difficult), 4. Auditory impairment (should be able to hear instructions correctly, with or without hearing Aid), 5. Cognitive impairment (MMS < 24) OUTCOME MEASURES: 1. Plantar flexor strength: Micro-FET HHD 2. Dorsiflexion ROM: Weight bearing lunge test 3. Case record: Fall risk assessment tool(FRAT) 4. Dynamic balance: TUGT 5. Anthropometric measures: BMI 6. Physical activity level: PASE Record of co-morbidities
PROCEDURE: • After the approval from the ethical committee, the subjects will be explained about study and a written informed consent will be taken. • The subjects will be assessed for (1) Plantar flexor muscle strength (predictor variable) (2) Dorsiflexion range and PASE (predictor variable), BMI, FRAT. The subjects will be instructed to perform TUG (outcome variable). • The subjects will be divided into two groups: Fallers and non-Fallers depending on their TUG score. • A logistic regression will be conducted to predict the likelihood of belonging to the fallers v/s non-fallers group, using the predictor variables of plantar flexor strength, dorsiflexion ROM, PASE and BMI. | | |