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Trial registered on ANZCTR


Registration number
ACTRN12625000113459
Ethics application status
Approved
Date submitted
29/10/2024
Date registered
31/01/2025
Date last updated
31/01/2025
Date data sharing statement initially provided
31/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Upper Limb Isometric Training on Hamstring Activation among Healthy Adults
Scientific title
Acute Effect of Upper Limb Isometric Training on Hamstring Activation among Able-Bodied Adults: A Cross-over Experimental Study
Secondary ID [1] 313259 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tightness and/or weakness in the hamstrings. 335580 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332153 332153 0 0
Physiotherapy
Musculoskeletal 332319 332319 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This crossover trial will take place at the Clinical Examination Laboratory of Hospital Canselor Tuanku Muhriz (HCTM) in Malaysia. Participants will be recruited via convenience sampling through advertisements on campus bulletin boards, social media groups, and the university staff email directory. Eligibility will be determined by a health questionnaire that assesses exclusion criteria, footedness, and dominant leg. Participants who meet the inclusion criteria will sign a consent form after receiving detailed information about the study.

Potential participants will be recruited to complete two sessions of bilateral upper limb isometric training (ULIT): (1) submaximal contraction and (2) maximal contraction. Each session will include three bilateral ULIT exercises performed in a standing position: Exercise 1: Isometric Wall Push-Up, Exercise 2: Isometric Shoulder Extension, and Exercise 3: Isometric Shoulder External Rotation. These exercises aim to target muscle groups across the posterior myofascial kinetic chain, considering possible interconnections with the hamstrings.

The Nicolet EDX system will assess changes in hamstring muscle activity using surface electrodes placed across the semitendinosus, biceps femoris, rectus abdominis, and lower trapezius muscles of the dominant limb. Electrodes are positioned parallel to the muscle fibers in accordance with the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) guidelines. Muscle activation will be measured using the root mean square (RMS) of peak amplitude. To improve interpretability, RMS values are expressed as percentages relative to a baseline and averaged over 5-second isometric contractions. Muscle activity ratios for each exercise are calculated using the following formula: Ratio (%) = (muscle activity during ULIT exercise/muscle activity during two-foot quiet standing) × 100.

Familiarisation Session:
Prior to the experimental trials, all participants will undergo a familiarisation session at least three days before the first intervention session to familiarise themselves with the ULIT protocol and the equipment used for hamstring activation measurements. During this session, participants will practice the isometric exercises and apply surface electromyography (sEMG) sensors to ensure proper placement and comfort. The final analysis will not utilise any data from the familiarisation session. The familiarisation session will last approximately 30 minutes.

Intervention Session:
The interventions will be conducted by a physiotherapist with more than five years of clinical experience. Following the attachment of the electrodes, there is a 15-minute interval before the intervention begins. An outcome evaluator, blinded to the intervention sequence and intensity, will assess outcome measurements at three time points: pre-intervention (baseline measurement), during the intervention exercise (primary outcome measure), and post-intervention (secondary outcome measure). Participants' baseline assessment is taken for the hamstring flexibility of the dominant leg, the maximal voluntary isometric contraction (MVIC) of hamstring peak force and muscle activation during two-foot quiet standing (anatomical position stance width). Each intervention exercise series will be conducted in a similar order, starting with a 5-second maximal effort trial for each exercise. Next, the participants will be verbally ordered to exert either 50% (submaximal ULIT session) or 100% (maximal contraction ULIT session) of their maximum effort, maintaining it for 5 seconds, followed by 5 seconds of rest between each repetition, for a total of 5 repetitions. To minimise muscular fatigue, a one-minute break is given between each exercise. During ULIT exercises, participants will have a hand-held dynamometer attached to their distal hand to monitor force production and ensure consistent effort. An additional effort will be performed if any measured strength exceeds or is less than 10% of the target. The total intervention session will last approximately 60 minutes.
Intervention code [1] 329838 0
Rehabilitation
Comparator / control treatment
This is a crossover trial that compares hamstring activation between submaximal and maximal ULIT contractions. During the next seven-day washout period, the participants will be returned to the same ULIT protocol for the second session, with varying intensities of contraction. The order of the intervention sessions will be randomised using computer-generated assignments.
Control group
Active

Outcomes
Primary outcome [1] 339738 0
The peak amplitude of hamstring activation during the Isometric Wall Push-Up exercise.
Timepoint [1] 339738 0
The primary data will be collected at baseline and will be continuously measured during the intervention exercise (the primary time point).
Primary outcome [2] 340155 0
The peak amplitude of hamstring activation during the Isometric Shoulder Extension exercise.
Timepoint [2] 340155 0
The primary data will be collected at baseline and will be continuously measured during the intervention exercise (the primary time point).
Primary outcome [3] 340156 0
The peak amplitude of hamstring activation during the Isometric Shoulder External Rotation exercise.
Timepoint [3] 340156 0
The primary data will be collected at baseline and will be continuously measured during the intervention exercise (the primary time point).
Secondary outcome [1] 441067 0
Hamstring flexibility
Timepoint [1] 441067 0
The secondary data will be collected at baseline and within 10 minutes after each intervention session.
Secondary outcome [2] 441138 0
Peak force of maximal voluntary isometric contraction of the hamstrings.
Timepoint [2] 441138 0
The secondary data will be collected at baseline and within 10 minutes after each intervention session.
Secondary outcome [3] 441139 0
Muscle fatigue and soreness over the upper limb and lower limb
Timepoint [3] 441139 0
Researchers will document any adverse events of muscle fatigue and soreness over the upper limb or lower limb via phone calls on day 3 post each intervention session.

Eligibility
Key inclusion criteria
Individuals who are 18 years to 45 years old among the staff and students of Universiti Kebangsaan Malaysia (UKM) with no known medical conditions.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Neurological deficit (radial nerve symptoms, carpel tunnel)
2) Surgery to elbow previous treatment to elbow including steroid injections within 4 weeks
of entering the study.
3) Inflammatory conditions affecting the elbow or wrist
4) Connective tissue disorders
5) Generalized myalgia, neuromuscular diseases
6) Cardiovascular diseases malignancies, haemophilia, diabetes.
7) Prescription medications such as beta-adrenoceptor blocking agents or anti-inflammatory or analgesic drugs
8) History of fracture to humerus, radius, or ulna.
9) Pregnancy
10) Hypermobility syndrome based on The Beighton Score.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The means and standard deviations of participant demographic data, including age, weight and height will be calculated. Before any inferential statistical analyses are performed, the distribution of raw data sets (baseline value of sEMG muscle activation in anatomical standing position, hamstring MVIC peak force, and AKET) will be checked using the Kolmogorov-Smirnov test. Assuming the data set is normally distributed, a paired t-test (2-tailed) will be used to test for differences between the mean values of Hamstring MVIC peak force. Otherwise, a non-parametric test, which is the Wilcoxon signed rank test, will be used. Furthermore, the ANOVA test is employed to explore the impact of different types of ULIT exercise on hamstring activation. If the within-group effect is statistically significant, the post hoc pairwise comparison is conducted using the Bonferroni correction test. In addition to the test of significance (a level set at p<0.05), the effect sizes and the confidence interval for the means will be estimated to determine the statistical power of interventions (submaximal vs maximal contraction). A Sensitivity Analysis will be used to link the conclusion and any missing data of this study, such as participants dropping out due to treatment side effects or other reasons directly related to their outcomes. The statistical analyses are conducted using the SPSS statistical software program (SPSS Inc., Chicago, IL, USA, Version 29.0).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 26658 0
Malaysia
State/province [1] 26658 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 317709 0
Hospital
Name [1] 317709 0
Hospital Canselor Tuanku Muhriz UKM
Country [1] 317709 0
Malaysia
Primary sponsor type
Hospital
Name
Hospital Canselor Tuanku Muhriz UKM
Address
Country
Malaysia
Secondary sponsor category [1] 320029 0
None
Name [1] 320029 0
Address [1] 320029 0
Country [1] 320029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316403 0
UKM Research Ethic Committee (RECUKM)
Ethics committee address [1] 316403 0
[email protected]
Ethics committee country [1] 316403 0
Malaysia
Date submitted for ethics approval [1] 316403 0
10/10/2024
Approval date [1] 316403 0
12/12/2024
Ethics approval number [1] 316403 0
JEP-2024-937

Summary
Brief summary
This study aims to evaluate the acute effects of upper limb isometric training (ULIT) on hamstring activation in able-bodied adults using surface electromyography (sEMG). We hypothesise that the ULIT will significantly improve hamstring activation. Fifteen participants will complete two intervention sessions: one involving submaximal ULIT contractions and another with maximal ULIT contractions, separated by a seven-day washout period. Each intervention session includes three isometric exercises targeting upper limb muscles linked to the posterior myofascial chain, potentially influencing the hamstrings. Hamstring activation will be assessed at baseline, during the exercises, and immediately post-intervention using sEMG to capture peak muscle activity. The findings will offer new insights into interlimb muscle coordination and the role of ULIT in influencing lower limb muscle activation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137778 0
A/Prof Badrul Akmal Hisham Bin Md. Yusoff
Address 137778 0
Hospital Canselor Tuanku Muhriz, UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 137778 0
Malaysia
Phone 137778 0
+60125196119
Fax 137778 0
Email 137778 0
[email protected]
Contact person for public queries
Name 137779 0
Efri Noor Bin Muhamad Hendri
Address 137779 0
Hospital Canselor Tuanku Muhriz, UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 137779 0
Malaysia
Phone 137779 0
+60132117407
Fax 137779 0
Email 137779 0
[email protected]
Contact person for scientific queries
Name 137780 0
Mohamad Shariff Bin A Hamid
Address 137780 0
Jabatan Perubatan Kesukanan, Tingkat 5, Menara Selatan, Pusat Perubatan Universiti Malaya, Lembah Pantai, 59100 Kuala Lumpur
Country 137780 0
Malaysia
Phone 137780 0
+60122065452
Fax 137780 0
Email 137780 0
[email protected]

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.