Evaluating the effect of beetroot extract supplementation coinciding with resistance training on maximum concentric peak torque and power of the quadriceps and hamstring muscles in semi-professional male athletes after anterior cruciate ligament surgery
Determining the effect of 4 weeks of beetroot extract supplement along with resistance training on body composition, maximum concentric torque, and power in quadriceps and hamstring muscles at 60, 120 and 300 degrees per second after ACL surgery
Design
Single arm, non-randomized, unblinded, phase 2 clinical trial on 23 male athletes
Settings and conduct
This study will be conducted in the filed of post ACL reconstruction surgery rehabilitation on 23 male athletes (18 to 35 years old) who underwent ACL reconstruction surgery 90 days prior to the study in a sports medicine center in Mashhad.
All subjects will follow a similar exercise protocol of 90-minute strength training 3 sessions per week for 4 weeks (overall 12 sessions).
Subjects will consume 250 ml beetroot extract containing 40% of ADI for nitrate based on their body weight, two hours before exercise in 2 non-consecutive sessions. Besides performing similar strength exercises, a nitrated restricted diet will be prescribed to the subjects.
Maximum concentric torque and quadriceps and hamstring power by isokinetic device and lean body mass by body composition analyzer will be assessed at baseline and 48 hours after the last exercise session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male athletes who have undergone ACL reconstruction surgery using the allograft technique 90 days prior to inclusion in the study.
No entry conditions: Allergy to beetroot, bilateral injuries to the knee and other tissues and ligaments of the knee, including intra-articular fractures, consuming beetroot extract less than 2 times a week during the study, failure to follow the diet and exercise program based on research protocol
Intervention groups
250 cc beetroot extract containing 40% ADI of nitrate per body weight
There is no control group
Main outcome variables
Strength and power of quadriceps and hamstrings, body composition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210217050393N2
Registration date:2021-07-26, 1400/05/04
Registration timing:registered_while_recruiting
Last update:2021-07-26, 1400/05/04
Update count:2
Registration date
2021-07-26, 1400/05/04
Registrant information
Name
REZA REZVANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2418
Email address
rezvanir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of beetroot extract supplementation coinciding with resistance training on maximum concentric peak torque and power of the quadriceps and hamstring muscles in semi-professional male athletes after anterior cruciate ligament surgery
Public title
Evaluating the effect of beetroot extract supplementation coinciding with resistance training in rehabilitation of athletes with anterior cruciate ligament rupture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male semi-professional athletes who play in provincial teams in the fields of football, futsal, volleyball and basketball
Undergoing ACL reconstructing surgery using allograft technique
90 days have passed since the ACL reconstruction surgery
Adhere to the same protocol, which includes 40 sessions of physiotherapy with 60 sessions of exercise therapy, from the day of surgery to the end of 90 days for all subjects
Willingness to participate in research
Age between 18 and 35 years old
Exclusion criteria:
Disease including: diabetes, kidney stones, gallstones, cancer and other serious diseases
Taking any medication or performing extra exercise compared to the research protocol
Using oral and injectable nutritional supplements before and after the research period
Consumption of any herbal medicine
Allergy to beetroot
Smoking
Alcohol consumption
History of performing any surgery on the operated limb
Bilateral knee injuries
Damage to other tissues and ligaments of the knee, including intra-articular fractures
Age
From 18 years old to 35 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is a single arm non-randomized trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.109
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament rehabilitation
ICD-10 code
M62.50
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified, unspecified site
Primary outcomes
1
Description
Maximum concentric torque of quadriceps and hamstring at 60 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 60 degree per second
2
Description
Maximum concentric torque of quadriceps and hamstring at 90 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 90 degree per second
3
Description
Maximum concentric torque of quadriceps and hamstring at120 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 120 degree per second
Secondary outcomes
1
Description
Lean body mass
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Body analyzer device
Intervention groups
1
Description
Intervention group: 250 cc beetroot extract containing 40% ADI nitrate based on body weight will be given to the athlete two hours before exercise in two non-consecutive sessions. The duration of the intervention will be 4 weeks, which includes 12 sessions of resistance training and 8 servings of beetroot supplement. Sachets containing extract powder will be prepared by the Mashhad School of Pharmacy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehregan Pars Physiotherapy Center
Full name of responsible person
Mohammad Hossein Khabaz Kababi
Street address
Mehregan Pars building, Next to the Shahid Aghdaei 1St, Vakilabad 35 Ave, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188957202
Phone
+98 51 3869 3007
Email
ahoseleh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code: 9177948564
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2418
Fax
Email
rezvanir@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code: 9177948564
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2418
Fax
Email
rezvanir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code: 9177948564
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2418
Fax
Email
rezvanir@mums.ac.ir
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