Comparison of long-term effects of active range of motion exercises with and without whole-body vibration on skeletal muscle index and physical performance in elderly population with sarcopenia
To determine the effects of Whole-Body Vibration (WBV) training on sarcopenia in the elderly population
Design
Assessor-blinded Randomized Control Trial of 56 community-dwelling older adults
Settings and conduct
Assessor-blinded Randomized Control Trial of 56 community-dwelling older adults at National Institute of Rehabilitation Science, Islamabad, Pakistan
Participants/Inclusion and exclusion criteria
Individuals with age 60 and above, meeting sarcopenia diagnostic criteria based on the European Working Group on Sarcopenia in Older Population (EWGSOP2) algorithm for case-finding and diagnosis with a negative Romberg's sign. Anyone meeting “severe” sarcopenia diagnostic criteria, having uncontrolled medical conditions, lower limb implants or taking drugs that affect neuromuscular system, won't be included.
Intervention groups
Intervention group will receive 10 bouts of WBV (frequency ranging from 15 to 40 Hz, Amplitude 1.2 mm with linear vibration) in the dynamic partial squat position while isometrically contracting quadriceps muscles during the vibration period, keeping knees and hips slightly flexed (20°) with 1 minute rest in between each bout for three days a week for 8 weeks. Control group will be made to perform 10 repetitions of similar dynamic partial squats with same position and duration with vibration platform turned off. Both groups will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between.
Main outcome variables
Skeletal Muscle Mass Index, Muscle strength, Physical performance, Functional mobility, Fall risk, Quality of life, Inflammatory markers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230304057612N1
Registration date:2023-04-26, 1402/02/06
Registration timing:prospective
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Shafaq Altaf
Name of organization / entity
Country
Pakistan
Phone
+92 343 5020507
Email address
sh-altaf@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of long-term effects of active range of motion exercises with and without whole-body vibration on skeletal muscle index and physical performance in elderly population with sarcopenia
Public title
Long-Term Effects of Whole-Body Vibration on Sarcopenia in Geriatric Population
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly aged 60 years and above
Participants who meet sarcopenia diagnostic criteria based on the EWGSOP2 algorithm for case-finding and diagnosis with Skeletal Muscle Index (SMI) <7.0 kg/m2 and <5.5 kg/m2 for males and females, respectively
Negative Romberg's sign
Participants who are willing to comply with the study protocol and give informed consent in writing
Exclusion criteria:
Participants who meet “severe” sarcopenia diagnostic criteria based on the EWGSOP2 algorithm for case-finding and diagnosis with a score of ≤8 on Short Physical Performance Battery (SPPB)
Presence of any neuromuscular, autoimmune, or infectious diseases
Participants with Total Hip Replacement, Total Knee Replacement and any other lower limb implants
Participants unable to flex the knee joints to 90° or having pain in their knees or ankles due to any problem such as arthritic changes
Participants with any critical cognitive (Mini–Mental State Examination, MMSE score < 23) or physical dysfunctions that may interfere with the test or training procedures
Participants with cardiovascular and/or pulmonary diseases, which can get aggravated after exercise
Participants who are taking drugs that can affect the neuromuscular system
Participants who are osteoporotic with T-score < -2.5 on DEXA at the lumbar spine/ femoral neck/distal third of the radius
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified block randomization method will be used using "Random Allocation Software", to achieve balance among groups. For this purpose, there are random blocks with a block size of 4 and an allocation ratio of 1 male to 1 female. After this step, a simple randomization procedure (flipping a coin) will be used to assign the participants within each block to one of the experimental or control groups. Therefore, there will be 4 groups with equal sizes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blinded to the participants’ allocation before intervention and posttest measures obtained after intervention. The patients will be unaware of which group they are allocated to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation, Tehran University of
Street address
Building no. 1, North Door of University, Poursina street, Ghods St, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1417755354
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
IR.TUMS.FNM.REC.1401.171
Health conditions studied
1
Description of health condition studied
Sarcopenia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skeletal Muscle Index (SMI)
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
Dual-energy X-ray absorptiometry (DEXA) will be carried out for each participant by the same technician. All assessments will be performed at the same time in the day around 10 a.m. to 12 noon.
2
Description
Muscle strength
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
Dynamometer for the hand grip strength and knee strength will be used. For measuring hand grip strength, participant will be asked to squeeze the handle of dynamometer as strongly as possible while three readings will be noted in kilograms from the alternate hand to relax the other hand. After three trials, the highest value of the 3 repetitions will be considered for each hand separately. For measuring maximal isometric strength of knee extensors, the participants will be instructed to sit with their hips and knees at 90 degrees flexion, legs perpendicular to the floor and the feet not touching the ground. The dynamometer will be placed just proximal to the ankle on the front leg. A high density foam pad may be placed between the dynamometer's force pad and the subjects' leg for comfort and to protect subjects' skin. During testing, the subjects will be instructed to contract maximally and to sustain the maximal voluntary contraction for 5 seconds. The highest value of the 3 measurements will be considered.
3
Description
Physical Performance
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
Mini Physical Performance Test will be used to measure balance, strength and mobility. It has 4 components: picking up a penny from floor, a timed 50-feet walk, chair rises (5 times) and a progressive Romberg test. Higher scores indicate better performance.
4
Description
Functional mobility
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
Timed Up and Go (TUG) will be administered to assess the changes in the functional mobility of the participant's walking. Measuring tape, chair with arm rest, tape to mark the ground and stopwatch will be used in this test. A 3-meter walkway will be measured by the tape. On one end, a chair would be placed facing down the walkway with front legs as the start point of the 3-meter distance. On the other end, a cone will be placed to serve as a marker. The participants will sit on a chair with their back against the back rest preparing for the test. The participant would be signaled to stand up, walk to the marker, turn around once reached to the marker in order to return to the chair and sit again. The time required by the participant to complete the test will be measured. An older adult who would take more than and equal to 12 seconds to complete TUG test will be at risk of falling.
5
Description
Fall risk
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
Falls Efficacy Scale-International which is a short, easy to administer tool that measures level of concern about falling during social and physical activities inside and outside the home whether or not the person usually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned) with score of 16 denoting no concern about falling while score of 64 denotes severe concern about falling.
Secondary outcomes
1
Description
Quality of life
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
SarQoL questionnaire which is a self-administered questionnaire comprising of 55 items and 22 questions and is organized into 7 domains of health related quality of life (QOL) including Physical and Mental Health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fears. Each domain is scored from 0 (worst QOL) to 100 (best QOL) and overall score is calculated.
2
Description
Inflammatory markers
Timepoint
before intervention, after intervention and 8 weeks post termination of intervention
Method of measurement
Plasma levels will be assessed for each participant in the pathologic lab through blood sample obtained from antecubital vein between 8 a.m. to 10 a.m.
Intervention groups
1
Description
Intervention group: It will contain subgroups of an equal number of males and females. This group will receive 10 bouts of WBV with frequency progressively increasing from 15 to 40 Hz (15Hz for 1st and 2nd week, 20Hz for 3rd and 4th week, 30Hz for 5th and 6th week, 40Hz for 7th and 8th week) and Amplitude 1.2 mm with linear vibration in the dynamic partial squat position while isometrically contracting quadriceps muscles during each vibration period (60 seconds), keeping knees and hips slightly flexed (20°) with 1 minute rest in between each bout for three days a week for 8 weeks. During treatment, participants will be made to hold hand railing under supervision of a trained physical therapist. Additionally, they will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between.
Category
Rehabilitation
2
Description
Control group: It will contain subgroups of an equal number of males and females. Control group will be made to perform 10 repetitions of similar dynamic partial squats with same position (knees and hips 20° flexed while isometrically contracting quadriceps muscles) and duration (60 seconds followed by 1-minute rest in between each repetition), three times a week for 8 weeks as in intervention group with vibration platform turned off. During treatment, participants will be made to hold hand railing under supervision of a trained physical therapist. Additionally, they will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Therapy, National Institute of Rehabilitation Medicine
Full name of responsible person
Dr. Vinod Kumar
Street address
Street no. 9, Sector G-8/2, Islamabad, Pakistan
City
Islamabad
Postal code
44080
Phone
+92 333 2097267
Email
dr.vinod.sawlani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi - Vice President of Research and Technology
Street address
Deputy of Research, 6th floor, Tehran University of Medical Sciences, Next to Ghods street, Keshavaez Boulvard
City
Tehran
Province
Tehran
Postal code
1417755354
Phone
+98 919 588 9548
Email
kmalmir@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shafaq Altaf
Position
PhD (Physical therapy) Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 64, Street 59, I-8/3, Islamabad
City
Islamabad
Province
Islamabad Capital Territory
Postal code
44000
Phone
+92 343 5020507
Email
shafaq.altaf.shah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malmir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, No. 336, Next to Safialishah Street, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 919 588 9548
Email
kmalmir@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shafaq Altaf
Position
PhD (Physical Therapy) Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 64, Street 59, Sector I-8/3
City
Islamabad
Province
Islamabad Capital Territory
Postal code
44000
Phone
+92 343 5020507
Email
shafaq.altaf.shah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Sharing IPD is of no use for our study. We should consider the whole sample size.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the primary outcome measure will be shared
When the data will become available and for how long
The data will be available 2 months after publication
To whom data/document is available
The results will be available for physiotherapists and people working in academic institutions
Under which criteria data/document could be used
People can use the data only for rehabilitative purposes
From where data/document is obtainable
Ms. Shafaq Altaf will be in-charge of communication via email: shafaq.altaf.shah@gmail.com
What processes are involved for a request to access data/document
After receiving such request and its purpose, we will respond within one month