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CTRI Number  CTRI/2025/05/087106 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of fitness exercise on Aerobic capacity, Anaerobic capacity, Muscular fitness, Flexibility, Grip strength, Static balance and social behavior in children with autism spectrum disorders. 
Scientific Title of Study   Effects of fitness exercise on Aerobic capacity, Anaerobic capacity, Muscular fitness, Flexibility, Grip strength, Static balance and social behavior in children with autism spectrum disorders. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr khushbu Naik 
Designation  Professor 
Affiliation  Shree Bharatimaiya college of optometry and Physiotherapy 
Address  Department of Physiotherapy,Shree bharatimaiya college of optometry & physiotherapy, Anand dham vruddhashram, behind big bazar, vesu surat

Surat
GUJARAT
395007
India 
Phone  09624818457  
Fax    
Email  drdesai88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr khushbu Naik 
Designation  Professor 
Affiliation  Shree Bharatimaiya college of optometry and Physiotherapy 
Address  Department of physiotherapy, 2nd floor, Shree bharatimaiya college of optometry & physiotherapy, anand dham vruddhashram, brhind big bazar,vesu surat

Surat
GUJARAT
395007
India 
Phone  09624818457  
Fax    
Email  drdesai88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr khushbu Naik 
Designation  Professor 
Affiliation  Shree Bharatimaiya college of optometry and Physiotherapy 
Address  Department of physiotherapy, 2nd floor,Shree bharatimaiya college of optometry & physiotherapy,anand dham vrudhashram, behind big bazar, vesu, surat

Surat
GUJARAT
395007
India 
Phone  09624818457  
Fax    
Email  drdesai88@gmail.com  
 
Source of Monetary or Material Support  
Shree Bhartimaiya college of optometry & Physiotherapy 
 
Primary Sponsor  
Name  Dr khushbu Naik 
Address  Physiotherapy department, 2nd floor, shree bharatimaiya college of optometry & Physiotherapy, Anand dham vruddhashram, behind big bazar, vesu, surat 395007  
Type of Sponsor  Other [self] 
 
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 Saravanan M  Shree Bharatimaiya college of optometry and Physiotherapy  Department of Physiotherapy, Pediatric physiotherapy room, 2nd floor, anand dham vruddhashram, vesu road, surat
Surat
GUJARAT 
9375985609

sandypie4ever@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shree Bharatimaiya College of Optometry and physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fitness exercise  comparision between 5 week protocol, 10 week protocol and control group 
Intervention  Fitness exercise  Grab Ball Complex (GBC) Ball Tap Complex (BTC) Hurdle Step-overs Bear Crawls Med ball/Sandbell overhead throws and slams Scramble Resistance Band Rotations Star Jumps 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Child with 1 and 2 levels of autism severity based on GARS-2
Child should be able to perform the requested exercise interventions
 
 
ExclusionCriteria 
Details  Child with any other complex neurologic disorder
(e.g. epilepsy, phenylketonuria, fragile X syndrome, and tuberous sclerosis).
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
six minute walk test
muscle power sprint test
long jump test
sit and reach test
hand grip
static balance
social behavior 
at baseline & post intervention (5 week & 10 week) 
 
Secondary Outcome  
Outcome  TimePoints 
height
weight
BMI 
at baseline & post-intervention (5 week & 10 week) 
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2025 
Date of Study Completion (India) 19/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/10/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
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  

AIM OF THIS STUDY:

The primary aim of this study will be,

(1)  To determine the effects of 5 week (3 session/week, 45 min per session) Fitness exercise on children with Autism spectrum disorders on their Aerobic fitness with 6 Minute Walk Test [sp1] , Anaerobic capacity with Muscle power sprint test, Muscular strength with standing long jump test, Flexibility with sit and reach test, Grip strength with Hand dynamometer, Static balance with single leg stand test with eyes open / closed and their social behavior with Social Responsiveness Rating Scale.

(2)  To determine the effects of 10 week (3 session/week, 45 min per session) Fitness exercise on children with Autism spectrum disorders on their Aerobic fitness with 6 Minute Walk Test, Anaerobic capacity with Muscle power sprint test, Muscular strength with long jump test, Flexibility with sit and reach test, Grip strength with Hand dynamometer, Static balance with single leg stand test with eyes open / closed and their social behavior with Social Responsiveness Rating Scale.

(3)  To compare the effectiveness of Fitness exercise on children with ASD between 5 weeks and 10 weeks of intervention on their Aerobic capacity, Anaerobic capacity, Muscular fitness, Flexibility, Grip strength, Static balance and Social behavior.

HYPOTHESIS:

(1)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Aerobic capacity measured using modified 6 Minute Walk Test.

(2)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Anaerobic capacity measured using Muscle Power Sprint Test.

(3)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on muscular strength measured using Standing long jump Test.

(4)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Flexibility measured using Sit and Reach Test

(5)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Grip strength measured using Hand grip dynamometer.

(6)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Balance measured using Single leg stance test.

(7)  There is significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on social behavior measured using Social Responsiveness Rating Scale.

NULL HYPOTHESIS

(1)  There is no significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Aerobic capacity measured using modified 6 Minute Walk Test.

(2)  There is no significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Anaerobic capacity measured using Muscle Power Sprint Test.

(3)  There is no significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on muscular strength measured using Standing long jump Test.

(4)  There is no significant difference between the effects of 5- and 10-week Fitness protocol in children with ASD on Flexibility measured using Sit and Reach Test.

INCLUSION CRITERIA:

The inclusion screening criteria will be:

(1)  Aged 3 to 14 years.

(2)  Both genders.

(3)  Having 1 and 2 levels of autism severity based on GARS-2

(4)  Ability to perform the requested exercise interventions.

(5)  Able to follow instructions.

EXCLUSION CRITERIA:

(1)  Having any other complex neurologic disorder

(e.g. epilepsy, phenylketonuria, fragile X syndrome, and tuberous sclerosis).

Procedure:

-          Group A (Control group) will be taking regular conventional therapy which include, Occupational therapy, balance training, motor skills activity and sensory integration techniques.

-          Group B will be continuing with conventional therapy along with 5 week of Fitness activity  (3 session per week, 45 min per session)

FITNESS EXERCISE PROTOCOL:

-          In this study, the fitness exercises will be consisted of Fitness exercise for Autism children by Eric Chessen, (AutismFitness.com, â„¢ 90 Sherman Ave, Williston Park, NY 11596, USA)

-          The exercises: Compound movements refer to activities that require several muscle groups toperform. These are “big” movements that have great generalization to other life skills including walking, carrying, balancing, cleaning, and engaging in novel play. They have chosen these exercises in particular because they include all the major movement patterns (pushing, pulling, rotation, bending, and locomotion), are fun, and relatively easy to teach. Any one of these movements can be broken down or made simpler in order to meet the needs of an individual or group. As the young athlete progresses, he/she can begin performing the movements in new sequences or with additional activities (hopping, throwing a ball after performing the exercise).

1) Grab Ball Complex (GBC):

- The child stands in front of the instructor/parent. Spot markers can be used to aid in spacial awareness.

- Instructor/parent holds a ball or Sandbell at arms length in various positions in front of the athlete. The athlete should have to bend, rotate, and reach to grab the object. One or two hands can be used, and the sequence (up, down,

right left) can be in a specific order or random.

2) Ball Tap Complex (BTC):

- Similar to the GBC, in the Ball Tap Complex the athlete holds the ball or Sandbell while the instructor/parent holds out a hand or other object. The athlete taps the hand with the ball/Sandbell. The target can be held in a variety of positions and presented in a particular sequence or random order.

 

 

3) Hurdle Step-overs:

- Using low (6”-1’) hurdles, the athlete steps over each hurdle in order. The knees should be raised high and the head should be looking forward. If knees turn inward or outward, the instructor/parent can prompt the athlete with both a physical cue (such as tapping the knee or holding a hand next to the foot) and behavior-specific praise (“You’re doing a great job picking that foot up high!”)

- Hurdles can be placed in any order, and can be performed walking forwards or backwards, and laterally (sideways) as well. For more advanced athletes, jumping over hurdles with both or one foot and changing up directions (backwards, forwards) can be a great challenge.

4) Bear Crawls

- Bear crawls are fantastic for any population. With particular regard for individuals with ASD, bear crawls develop kinesthetic or body awareness, trunk strength, shoulder stability, and motor planning.

- Begin in quadruped position (knees and hands on floor).

- Extend legs until slightly bent, and walk using feet and hands to move across an area. Palms should make contact with floor and fingers should be spread wide.

- Bear crawl can be assisted by prompting or guiding from the hips.

- Bear crawl can be performed forwards, backwards, laterally (right or left), and with varying speeds.

5) Med ball/Sandbell overhead throws and slams

- Throwing and slamming weighted objects increases core strength, balance, and has some implications in stimulating brain centers responsible for shortterm memory. It is also a skill that has great carryover to daily life skills and social play.

- Beginning in a standing position (spot markers can be used), the athlete

raises the ball overhead and throws to partner. For the slam, the ball/Sandbell is raised overhead and thrown onto the floor (or onto a specific target) with as much force as possible (don’t worry, it’s good for them).

- Throwing progressions can include jumping and throwing, or scoop throws

(holding the ball between the legs and scooping it forward to throw).

6) Scramble

- An awesome interactive activity made popular by IYCA Founder Brian Grasso. The Scramble can include many different movements beyond those listed here. It is a superb warm-up game that can be used with individuals or groups. It requires and develops listening skills, discrimination between movements and cues, and balance.

- Athlete begins prone (lying on stomach) on soft surface (an exercise or yoga mat works great). This is the 1st position. Position 2 is knees and hands on floor (quadruped), position 3 is quickly standing/bending knees, and position 4 is jumping up. Instructor can use specific verbal cues “Stomach, knees and hands, jump up” or other, more abstract cues such as one clap for stomach, two claps for knees and hands, three claps for standing, and four claps for jump up.

7) Resistance Band Rotations

- Rotation is important for spine and back health and is a particularly challenging movement pattern for young individuals with autism. Rotational movements strengthen the muscles around the spine as well as the core musculature. Rotation should not be a “let’s see how far we can turn” movement. It is safest when turning to less-than-parallel with our hip bone.

For the band rotation, a resistance band is placed in a doorway jamb securely fastened with a strap, or held by the instructor. The athlete grabs the band with both hands (one over the other) and rotates right and left. The movement should be controlled and the head should be positioned neutrally, not turning right or left with the upper body. Rotations can also be performed with a Sandbell or med ball.

8) Star Jumps

- Star Jumps can be performed singularly or in multiple repetitions. They can also be done jumping forward, backwards, or laterally by more advanced athletes. The athlete begins in a squatting position with feet flat on the floor and arms tucked in so that the elbows touch the knees. On the instructor’s cue, the athlete jumps up with arms and legs out, returning to squatting position with arms and legs tucked in. Repeat for up to 20 repetitions (or

until fatigue is evident).

-          Group C will be continuing their conventional therapy and 10 weeks of Fitness Activity (3 session per week, 60 min per session). Fitness activity protocol will be same as above mentioned. 


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