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CTRI Number  CTRI/2025/08/093436 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Resistance and Balance Training on Muscle function and Balance in Older People with Sarcopenia : A Randomized Controlled Trial 
Scientific Title of Study   Effect of Resistance and Balance Training on Muscle function and Balance in Older People with Sarcopenia : 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  Moksha Ranka 
Designation  Under Graduate Student 
Affiliation  Dr APJ Abdul Kalam College of Physiotherapy 
Address  Dr APJ Abdul Kalam College of Physiotherapy Community Physiotherapy Department 404 Pravara Institute of Medical Science Loni Tal - Rahata Dist- Ahmadnagar Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8830646041  
Fax    
Email  moksharanka65@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepali Hande 
Designation  Professor and Head of Department 
Affiliation  Dr APJ Abdul Kalam College of Physiotherapy 
Address  Dr APJ Abdul Kalam College of Physiotherapy Community Physiotherapy department 404 Pravara Institute of Medical Science Loni Tal - Rahata Dist- Ahmadnagar Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8275034001  
Fax    
Email  deepali.hande@pmtpims.org  
 
Details of Contact Person
Public Query  
Name  Dr Deepali Hande 
Designation  Professor and Head of Department 
Affiliation  Dr APJ Abdul Kalam College of Physiotherapy 
Address  Dr APJ Abdul Kalam College of Physiotherapy Community Phyiotherapy Department 404 Pravara Institute of Medical Science Loni Tal - Rahata Dist- Ahmadnagar Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8275034001  
Fax    
Email  deepali.hande@pmtpims.org  
 
Source of Monetary or Material Support  
Community Physiotherapy Department Dr APJ Abdul Kalam College of Physiotherapy PIMS DU Loni TAL Rahata DIST Ahmadnagar Maharashtra 413736 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Moksha Ranka  Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences  OPD No-404 Fourth Floor Community Physiotherapy Department Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 8830646041

moksharanka65@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CONTROL   The control group will participat in a balance exercise program Each session begins with a warm up of approximately ten minutes consisting of stretching and walking This will be followed by twenty to twenty five minutes of balance training which included heel and toe raise varied directional quick stepping reach outs single leg standing heel to toe walking complex cross over stepping weight shifts tandem standing tandem walking and wobble board practice Each exercise is performed for ten repetitions and two sets The session will be concluded with a cool down of about ten minutes consisting of static stretching and relaxation 
Comparator Agent  EXPERIMENTAL   The intervention group will participat in a varied exercise program that included both balance and resistance training Each session begins with a warm-up of approximately ten minutes consisting of stretching and walking This will be followed by twenty to twenty-five minutes of balance training which included exercises such as heel and toe raises varied directional quick stepping reach outs single leg standing heel to toe walking complex crossover stepping weight shifts tandem standing tandem walking and wobble board practice Each exercise was performed for ten repetitions and two sets After a short break participants will complete another twenty to twenty-five minutes of resistance training which incorporated hip flexion and extension with a theraband hip abduction and adduction with a theraband prone knee extension with a theraband biceps curls shoulder press leg press chest press and squats The resistance training will follow the FITT principle with a frequency of four days per week intensity kept at low to moderate level time set at ten repetitions for two sets and type involving therabands resistance bands and bodyweight based exercises Each session will conclude with a cool-down period of about ten minutes consisting of static stretching and relaxation 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1 Participants of 60 years and above age
2 Participants diagnosed with sarcopenia based on SARC – CalF score more than or equal to 11
3 Participants who are Independent in activities of daily living (ADLs) with no severe mobility restrictions
4 Participants with intact cognitive function, [Mini-Mental State Examination (MMSE) score of more than equal to 24]
5 Participants Capable of engaging in low to moderate-intensity exercise
6 Participants willing to participate
 
 
ExclusionCriteria 
Details  1 Participants with Severe osteoarthritis musculoskeletal disorders or recent fractures limiting physical activity
2 Participants with any Neurological conditions such as Parkinsons disease stroke or peripheral neuropathy affecting balance and movement
3 Participants with Severe cardiovascular disease (eg uncontrolled hypertension recent myocardial infarction or heart failure)
4 Participants having Uncontrolled diabetes or any metabolic disorder affecting muscle function
5 Participants who are currently engaged in structured resistance or balance training programs
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
SARC-CalF Questionnaire
Berg Balance Scale
TUG
 		 week 0-week8
 
 
Secondary Outcome  
Outcome  TimePoints 
Barthel Index  week 0-week 8 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   05/09/2025 
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  

Sarcopenia is a progressive loss of skeletal muscle mass strength and function that increases with age and is linked to falls frailty disability poor quality of life and mortality Muscle mass may decline up to 40 percent between ages 20 and 70 and at a rate of about 14 to 25 percent per year after 60 Aging leads to reduction of type 2 fibers fat infiltration and impaired satellite cell function along with systemic changes such as endocrine decline neuromuscular dysfunction insulin resistance mitochondrial dysfunction oxidative stress and denervation Risk factors include age gender and low physical activity Resistance training is the most effective strategy to slow muscle decline and physical activity in general is protective Progressive resistance training improves strength mass and functional ability Balance training enhances stability coordination proprioception and fall prevention while also activating core and lower limb muscles Together resistance and balance training provide greater benefits than either alone by improving strength mobility neuromuscular control and independence thereby enhancing quality of life There is a strong need for structured research as most current interventions focus only on nutrition and general activity and there are very few studies focusing on resistance and balance training Combined resistance and balance programs may provide superior outcomes This study aims to evaluate the effectiveness of a structured resistance and balance training program in enhancing muscle strength, functional mobility, balance, and overall quality of life in older adults with sarcopenia The objectives are to assess improvements in muscle strength calf circumference balance functional independence and fear of falls and to compare resistance training alone with combined training in older adults with sarcopenia

MATHEDOLOGY AND MATERIAL The study will be carried out in the Community Physiotherapy Department Dr APJ Abdul Kalam College of Physiotherapy over a duration of one year Data will be collected primarily by the principal investigator and will be quantitative in nature The study will follow a randomized control trial design and will be experimental in type A simple random sampling method will be used with a sample size of fifty The study population will include patients reporting to the Department of Community Physiotherapy Dr APJ Abdul Kalam College of Physiotherapy Pravara Medical Trust Loni Ahilyanagar The tools used for assessment will include the SARC CalF Questionnaire Berg Balance Scale and Barthel Index The materials required for the study will consist of informed consent forms stationery inch tape theraband or resistance band theradisk or wobble board cones chair stepper and stopwatch

OUTCOME MEASURES: Primary Outcome Measures :- 

1. SARC-CalF Questionnaire

2. Berg Balance Scale 

3. TUG 

Secondary Outcome Measure :-

 1. Barthel Index

INTERVENTION 

CONVENTIONAL GROUP 

The control group participates in a balance exercise program During every session, attendees will undergo a 5-minute warm-up session followed by 20 minutes of balance training. Subsequently, they will receive a 5-minute break, after which there will be 20 minutes of resistance training, culminating in a cool-down exercise. 

 WARM UP STRETCHING, WALKING 10 MINUTES

 BALANCE EXERCISE 20-25 MINUTES 10 Reps x 2 Sets

1. Heel and Toe Raise 

 2. varied directional Quick steeping 

 3. reach outs 

 4. single leg standing

 5. heel to toe walking

 6. complex cross over Steeping 

 7. weight shifts 

8. tandem standing 

 9. tandem walking 

10. wobble board 

 COOL DWON STATIC STRETCHING RELAXATION 10 MINUTES 

EXPERIMENTAL GROUP

 The intervention group participated in a varied exercise program that included both balance and resistance training. During every session, the participants underwent a brief 5-minute warm-up, followed by 20 minutes of specific balance training. Subsequently, they received a five-minute break before engaging in another 20 minutes of resistance training. Every session concluded with a 5-minute cool-down that included stretching 

WARM UP STRETCHING  WALKING 10 MINUTES

BALANCE EXERCISE  20-25 MINUTES 10 Reps x 2 Sets

1. Heel and Toe Raise 

2. varied directional Quick steeping 

 3. reach outs 

 4. single leg standing 

 5. heel to toe walking 

 6. complex cross over Steeping 

 7. weight shifts 

8. tandem standing 

 9. tandem walking 

10. wobble board 

RESISTANCE EXERCISE  20-25 MINUTES

According to FIIT Principle F : 4 Days/Week 

                                           I : low to moderate Intensity 

                                           T : 10 Reps x 2 Sets 

                                           T: Theraband / Resistance band And bodyweight – based

1. Hip flexion and Extension (theraband) 

2. Hip abduction And adduction (theraband) 

3. Prone Knee Extension (theraband) 

4. Biceps curls 

 5. Shoulder press 

6. Leg Press 

 7. Chest press 

 8. Squats 

 COOL DWON STATIC STRETCHING RELAXATION 10 MINUTES 

 
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