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The Effect of Six Weeks of Corrective Exercises Combined with Hydrolyzed Collagen and Vitamin C Supplementation on Pain, Function, and Quality of Life in Female Athletes Players with Achilles Tendinopathy

Protocol summary

Study aim
The Effect of Six Weeks of Corrective Exercises Combined with Hydrolyzed Collagen and Vitamin C Supplementation on Pain, Function, and Quality of Life in Female Athletes Players with Achilles Tendinopathy
Design
The study design is a phase 3, placebo‑controlled, single‑blind (participant‑blinded only), randomized clinical trial in which 30 participants will be allocated into two equal groups—experimental (n=15) and control (n=15)—using block randomization.
Settings and conduct
The study will be conducted at the Faculty of Sport Sciences, Razi University (Kermanshah); exercise sessions take place in the corrective exercise hall, while assessments and supplement distribution are performed in the motion analysis laboratory and clinic by a blinded assessor.
Participants/Inclusion and exclusion criteria
Inclusion Conditions 1. Active ankle range of motion with at least ۱۰ degrees of dorsiflexion to ensure proper execution of corrective exercises. 2. Written commitment to attend all training sessions regularly (at least ۸۰% attendance) and to refrain from any concurrent therapeutic interventions for the Achilles. Exclusion Conditions Occurrence of any acute injury in the lower extremity (knee, hip, or back) within ۴ weeks prior to the study that affects gait pattern. History of taking supplements containing collagen, vitamin C, or other tendon‑affecting compounds within ۴ weeks before study initiation.
Intervention groups
In this trial, the experimental group will receive 30 grams of hydrolyzed collagen plus 500 mg of vitamin C daily, while the control group will receive a maltodextrin placebo plus vitamin C, with both groups consuming their respective supplements one hour prior to performing three weekly sessions of corrective exercises (eccentric, balance, and neuromuscular) based on the Alfredson protocol.
Main outcome variables
Pain, Function, QoL

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260605069646N1
Registration date: 2026-07-10, 1405/04/19
Registration timing: prospective

Last update: 2026-07-10, 1405/04/19
Update count: 0
Registration date
2026-07-10, 1405/04/19
Registrant information
Name
Asal Besanj
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 9714
Email address
asalbesanj@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-08-01, 1405/05/10
Expected recruitment end date
2026-10-02, 1405/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Six Weeks of Corrective Exercises Combined with Hydrolyzed Collagen and Vitamin C Supplementation on Pain, Function, and Quality of Life in Female Athletes Players with Achilles Tendinopathy
Public title
Effect of Six‑Week Corrective Exercise and Collagen‑Vitamin C Supplementation on Pain, Function, and Quality of Life in Female Athletes with Achilles Tendinopathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of mid‑portion Achilles tendinopathy (pain and tenderness ۲–۶ cm above insertion) confirmed by a specialist or imaging (ultrasound/MRI). Recreational to semi‑professional female athletes with at least ۳ exercise sessions per week, aged ۱۸–۴۵ years. Pain intensity ≥ ۳/۱۰ on Visual Analogue Scale (VAS) during daily or sports activity for at least the past ۴ weeks.
Exclusion criteria:
History of Achilles surgery, complete rupture, corticosteroid or PRP injection in the last ۶ months Systemic diseases affecting tissue repair (uncontrolled diabetes, rheumatoid arthritis, renal failure) or allergy to collagen/vitamin C. Pregnancy, lactation, regular use of analgesics/NSAIDs in the ۲ weeks prior to the study, or concurrent participation in other targeted physiotherapy/exercise interventions for Achilles.
Age
From 18 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using block randomization with block sizes of 4 (or 6). The allocation sequence is generated by statistical software or a random number table and placed in sequentially numbered, opaque, sealed envelopes. Group allocation is carried out by an independent individual (not involved in assessment or intervention delivery) to ensure allocation concealment. The outcome assessor and participants remain blinded to group assignment (assessor‑blinded design).
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is applied only to participants. Both groups receive the same corrective exercise program, but participants are unaware of which supplement they are taking. The active supplement (collagen + vitamin C) and placebo are completely identical in appearance, odor, taste, color, size, and packaging, and are coded by an individual independent of the research team. Thus, participants do not know whether they are in the supplement or placebo group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Razi University of Kermanshah
Street address
No. 8, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2026-05-12, 1405/02/22
Ethics committee reference number
IR.RAZI.REC.1405.011

Health conditions studied

1

Description of health condition studied
Female Athletes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Measurement time points are two: baseline (week 0) and post‑test (week 6).
Method of measurement
pain via Visual Analogue Scale (VAS, 0‑10) during sports activity

2

Description
Achilles‑specific function
Timepoint
Measurement time points are two: baseline (week 0) and post‑test (week 6).
Method of measurement
function via the VISA‑A questionnaire (8 items, 0‑100)

3

Description
Quality of life/daily functional
Timepoint
Measurement time points are two: baseline (week 0) and post‑test (week 6).
Method of measurement
Quality of life/daily function via the Lower Extremity Functional Scale (LEFS, 20 items, 0‑80)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group (n=15) consumes 30 g of hydrolyzed collagen plus 500 mg of vitamin C one hour before each corrective exercise session, performed three times per week for six weeks.
Category
Prevention

2

Description
Control group: The control group (n=15) consumes a placebo (maltodextrin plus 500 mg of vitamin C) one hour before each corrective exercise session, performed three times per week for six weeks, following the same exercise protocol as the intervention group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Ubiversity
Full name of responsible person
Asal Basenj
Street address
No. 8, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah, Iran
City
Kermanshah
Province
Kerman
Postal code
6714414971
Phone
+98 83 3428 3270
Email
asalbesanj@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi Univeristy
Full name of responsible person
Kivan Amini
Street address
No. 9, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
Keyvan.Amini@Gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Univeristy
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
Razi University
Full name of responsible person
Hidar Menochari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pathology and Corrective Exercises
Street address
No. 9, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
mhaidary2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Menocher Hidary
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pathology and Corrective Exercises
Street address
No. 9, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
mhaidary2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Asal Basanj
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Pathology and Corrective Exercises
Street address
No. 9, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
asalbesanj@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Not applicable
Title and more details about the data/document
All data will be recorded in the SPSS software and will be available
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as a reference
From where data/document is obtainable
asalbesanj@gmail.com
What processes are involved for a request to access data/document
All data can be used as a reference
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