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Trial registered on ANZCTR


Registration number
ACTRN12624001445561
Ethics application status
Approved
Date submitted
19/10/2024
Date registered
11/12/2024
Date last updated
11/12/2024
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Upper Limb Isometric Training on Hamstring Strength after Anterior Cruciate Ligament Reconstruction
Scientific title
Effect of Upper Limb Isometric Training on Hamstring Strength in Early Postoperative Anterior Cruciate Ligament Reconstruction Patients: A Randomised Controlled Trial
Secondary ID [1] 313318 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Reconstruction (ACLR) 335122 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331622 331622 0 0
Physiotherapy
Musculoskeletal 332233 332233 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in the Upper Limb Isometric Training (ULIT) alongside the standard care rehabilitation program. Participants will follow the standard care rehabilitation as outpatients from week 1 post-ACLR and the prescribed home exercise program. Starting in week 4 and continuing through week 12 post-ACLR, participants will integrate the ULIT into their warm-up and home exercise program in addition to standard ACLR rehabilitation, approximately lasting an hour per session.
A physiotherapist with more than five years of clinical experience will administer the ULIT program to participants following anterior cruciate ligament reconstruction (ACLR) surgery at an outpatient physiotherapy clinic. This will involve verbal instructions, demonstrations, and written materials. The program includes three standing exercises—an isometric wall push-up, isometric shoulder extension, and isometric shoulder external rotation.

General Exercise Instructions:
Finding Suitable Walls and Floors: Use a sturdy wall, ideally made of concrete, brick, or drywall supported by a stud frame, and avoid any walls with sharp edges. This ensures stability under applied force. Floors should have excellent traction, such as rubber mats or non-slip tiles, to prevent slipping.
Standing Position: Stand upright with feet shoulder-width apart. Maintain a neutral alignment of the lower back and hip, with knees fully extended and weight distributed evenly across both feet.
Effort Level: Begin each exercise with 100% effort for the first repetition. Perform the remaining 5 repetitions at 50% of maximum effort.
Repetition Structure: Hold each position for 5 seconds, followed by a 5-second rest. Complete a total of 5 repetitions per exercise. Perform 1 set of each exercise, 1–2 times daily.
Rest: Allow the upper limb muscles to relax and step back slightly from the wall to rest for 1 minute before starting the next exercise.

Additional adherence measures:
Materials provided: Patients will receive an exercise pamphlet and an online exercise diary to facilitate adherence to the program.
Self-reporting and monitoring: Participants are advised to follow the home exercise program guidelines included in their informational flyers. They will ask to complete a weekly exercise diary using an online Google Form. The physiotherapist will communicate with the participants weekly via phone or WhatsApp to reinforce adherence to the exercise program.
Intervention code [1] 329479 0
Rehabilitation
Intervention code [2] 329898 0
Treatment: Other
Comparator / control treatment
Participants will adhere to the standard-care ACLR rehabilitation protocol from the preoperative phase until 12 weeks post-ACLR. The Physiotherapy Unit of Hospital Cancelor Tuanku Muhriz will deliver standard physiotherapy care to both study groups, tailoring it to address the specific goals of each client and the timeline associated with ACLR recovery. The standard care emphasises knee mobilisation exercises, cryotherapy, and progressive strength and neuromuscular control exercises, including eccentric strengthening exercises, proprioceptive training, and dynamic stabilisation drills. The standard outpatient physiotherapy program takes about one hour per session, with a recommendation of 1-2 sessions per week until three months post-operative. All participants are encouraged to follow the designated daily home exercise program diligently.
Control group
Active

Outcomes
Primary outcome [1] 339352 0
Maximum voluntary isometric contraction of the hamstring peak force
Timepoint [1] 339352 0
Pre-operative, 4-, 8-, and 12 (primary timepoint) -weeks following ACLR
Primary outcome [2] 339810 0
Maximum voluntary isometric contraction of the quadriceps peak force
Timepoint [2] 339810 0
Pre-operative, 4-, 8-, and 12 (primary timepoint) -weeks following ACLR
Secondary outcome [1] 439618 0
To measure changes in physical function in the intervention group compared to the standard care group at preoperative and 12 weeks post-ACLR.
Timepoint [1] 439618 0
Preoperative and at 12 weeks post ACLR
Secondary outcome [2] 439619 0
To evaluate the effect of ULIT on hamstring flexibility at preoperative and 12 weeks post-ACLR.
Timepoint [2] 439619 0
Baseline and at 12 weeks post ACLR

Eligibility
Key inclusion criteria
The inclusion criteria are as follows: individuals who plan for ACLR using a ipsilateral hamstring tendon autograft, with or without a meniscal injury, capable of understanding English and giving informed consent, and are aged between 18 to 45 years.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with a revision ACL surgery, a multi-ligament injury (such as instability in the collateral, posterolateral, medial, or posterior cruciate ligaments), the use of allografts, an upper limb and contralateral lower limb injury after ACL surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The concealment is achieved using a set of sealed and numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization process will be performed using a computer-generated sequence numbering scheme ranging from one (1) to thirty-two (32), with an equal allocation ratio of 1:1.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data analysis will be conducted using the SPSS Windows Version 29.0 software (SPSS, Chicago, IL, USA). The data will be summarised using descriptive statistics such as the mean and standard deviation, median and interquartile range, quantity and percentage, and frequency, depending on the distribution and type of data. This encompasses participant demographics as well as adherence to exercise. To evaluate the normality of the data, we will examine the skewness and kurtosis statistics (the ratio of the statistic to the standard error) by conducting the Shapiro-Wilk test. Boxplots are employed to detect outliers.
The main outcome measure, the mean changes in hamstring isometric peak force between 4 and 12 weeks, will be assessed using a paired t-test. The main hypothesis will be tested by comparing the changes in the mean difference between the intervention group and the standard care group. The missing data will be analysed according to the intention-to-treat concept, considering the groups to which participants have been randomly allocated. Descriptive analysis, on the other hand, will describe missing data patterns in great detail to look for possible biases. If the data distribution exhibits non-normality or ceiling/floor effects, a non-parametric test (specifically, the Mann-Whitney test) will be conducted. Furthermore, this study will employ one-way repeated-measures ANOVA within-group measurements to investigate potential differences between the Quadriceps Index and Hamstring Index over an interval of time.
The secondary outcome data, which includes measurements of hamstring flexibility, range of motion, IKDC scores, and exercise adherence, will be summarised and evaluated in a manner consistent with the primary result. A repeated measures analysis of variance (ANOVA) will be used to examine the impact of rehabilitation and time on all the measured variables.
Statistical significance will be determined by a p-value of less than 0.05 (two-tailed) for all conducted tests with a 95% confidence interval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/12/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 26556 0
Malaysia
State/province [1] 26556 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 317382 0
Hospital
Name [1] 317382 0
Hospital Cancelor Tuanku Muhriz
Country [1] 317382 0
Malaysia
Primary sponsor type
Hospital
Name
Hospital Cancelor Tuanku Muhriz
Address
Country
Malaysia
Secondary sponsor category [1] 319672 0
None
Name [1] 319672 0
Address [1] 319672 0
Country [1] 319672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316111 0
Universiti Kebangsaan Malaysia Research Ethic Committee (RECUKM)
Ethics committee address [1] 316111 0
Ethics committee country [1] 316111 0
Malaysia
Date submitted for ethics approval [1] 316111 0
24/09/2024
Approval date [1] 316111 0
24/11/2024
Ethics approval number [1] 316111 0
JEP-2024-860

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136822 0
A/Prof Badrul Akmal Hisham Bin Md. Yusoff
Address 136822 0
Hospital Cancelor Tuanku Muhriz, UKM, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 136822 0
Malaysia
Phone 136822 0
+60125196119
Fax 136822 0
Email 136822 0
badrul.akmal.hisham.md.yusof@ppukm.ukm.edu.my
Contact person for public queries
Name 136823 0
Efri Noor Bin Muhamad Hendri
Address 136823 0
Hospital Cancelor Tuanku Muhriz, UKM, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 136823 0
Malaysia
Phone 136823 0
+60132117407
Fax 136823 0
Email 136823 0
efri.noor.muhamad.hendri@hctm.ukm.edu.my
Contact person for scientific queries
Name 136824 0
Mohamad Shariff Bin A Hamid
Address 136824 0
Jabatan Perubatan Kesukanan, Tingkat 5, Menara Selatan, Pusat Perubatan Universiti Malaya, Lembah Pantai, 59100 Kuala Lumpur
Country 136824 0
Malaysia
Phone 136824 0
+60122065452
Fax 136824 0
Email 136824 0
ayip@um.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.