Protocol summary
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Study aim
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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, 90 and 120 degrees per second after ACL surgery
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Design
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Non-randomized, parallel, unblinded, phase 2 clinical trial on 46 male athletes
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Settings and conduct
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This study will be conducted in the filed of post ACL reconstruction surgery rehabilitation on 46 male athletes (18 to 35 years old) who underwent ACL reconstruction surgery (after 90 days) in a sports medicine center in Mashhad.
All subjects (intervention and control groups) will follow a similar exercise protocol of 90-minute strength training 3 sessions per week for 4 weeks (overall 12 sessions).
The intervention group will also consume 250 ml beetroot extract (40% ADI for nitrate), two hours before exercise in 2 non-consecutive sessions. A list of nitrate rich foods will be given to subjects to reduce dietary nitrate intake.
Maximum concentric torque and quadriceps and hamstring power by isokinetic device and body composition by body composition analyzer will be assessed at baseline and 48 hours after the last exercise session.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Male athletes who have undergone ACL reconstruction (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
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Intervention groups
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Intervention group: 250 cc beetroot extract (40% ADI of nitrate) with resistance exercise
Control group: Resistance exercise
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Main outcome variables
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Strength and power of quadriceps and hamstrings, body composition
General information
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Reason for update
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Failure to update previous revision
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210217050393N2
Registration date:
2021-07-26, 1400/05/04
Registration timing:
registered_while_recruiting
Last update:
2022-10-21, 1401/07/29
Update count:
2
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Registration date
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2021-07-26, 1400/05/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-22, 1400/04/01
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Expected recruitment end date
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2021-12-22, 1400/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluating the effect of beetroot extract supplementation coinciding with resistance training in rehabilitation of athletes with anterior cruciate ligament rupture
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Male
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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This study is a non-randomized parallel clinical trial with control group
Ethics committees
1
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Ethics committee
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Approval date
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2021-04-20, 1400/01/31
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1400.109
Health conditions studied
1
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Description of health condition studied
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Anterior cruciate ligament rehabilitation
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ICD-10 code
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M62.50
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ICD-10 code description
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Muscle wasting and atrophy, not elsewhere classified, unspecified site
Primary outcomes
1
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Description
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Maximum concentric torque of quadriceps and hamstring at 60 degree per second
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Isokinetic device at 60 degree per second
2
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Description
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Maximum concentric torque of quadriceps and hamstring at 90 degree per second
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Isokinetic device at 90 degree per second
3
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Description
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Maximum concentric torque of quadriceps and hamstring at120 degree per second
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Isokinetic device at 120 degree per second
4
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Description
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Power of quadriceps and hamstring muscles at 60 degree per second
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Isokinetic device at 60 degree per second
5
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Description
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Power of quadriceps and hamstring muscles at 90 degree per second
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Isokinetic device at 90 degree per second
6
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Description
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Power of quadriceps and hamstring muscles at 120 degree per second
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Isokinetic device at 120 degree per second
Secondary outcomes
1
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Description
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body composition
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Timepoint
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Baseline and 48 hours after the last exercise session (4 weeks)
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Method of measurement
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Body analyzer device
Intervention groups
1
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Description
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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
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Category
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Rehabilitation
2
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Description
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Control group: Resistance training for 4 weeks including 12 resistance training sessions.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available