NCT06825052

Brief Summary

This study investigates the effects of deloading periods (short breaks or reductions in training volume) in a 8-week resistance training program on muscle strength and hypertrophy in young, untrained individuals. Participants were randomly assigned to two training conditions: Deload Training Group: Reduced training volume for one week every four weeks. Continuous Training Group: Regular training without reductions. Muscle thickness was measured using ultrasound, and muscle strength was evaluated through a 10-repetition maximum (10RM) test before and after the intervention. The findings showed that both training strategies led to significant increases in muscle strength and size, with no major differences between groups. This suggests that incorporating deloading periods does not negatively impact muscle development and may serve as an effective alternative for individuals with time constraints or minor injuries. This study was conducted at Gaziantep University, Faculty of Sports Sciences, with approval from the university's ethics committee.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 4, 2025

Last Update Submit

February 7, 2025

Conditions

Keywords

Muscle hypertrophymuscle strengthresistance training

Outcome Measures

Primary Outcomes (1)

  • Muscular Strength

    Changes in muscle strength will be assessed using 10-repetition maximum (10RM) testing before and after the intervention. Strength assessments will be conducted for both the quadriceps (leg extension) and biceps brachii (dumbbell curl).

    Baseline and after 8 weeks

Secondary Outcomes (1)

  • Muscle Hypertrophy

    Baseline and after 8 weeks

Study Arms (2)

Deload Training

EXPERIMENTAL

Participants in this group followed an 8-week resistance training program with deloading periods every four weeks. During these deload weeks, training volume and intensity were reduced to facilitate recovery while maintaining training adaptations.

Behavioral: Resistance Training with Deloading Periods

Continuous Training

ACTIVE COMPARATOR

Participants in this group followed an 8-week continuous resistance training program with no reductions in training volume or intensity. This group served as a comparison to assess the effects of deloading periods on muscle hypertrophy and strength.

Behavioral: Continuous Resistance Training

Interventions

Participants performed an 8-week unilateral resistance training program in which training volume and intensity were reduced during weeks 4 and 8 to facilitate recovery and adaptation.

Deload Training

Participants followed an 8-week unilateral resistance training program without any deloading periods. Training volume and intensity remained consistent throughout the study.

Continuous Training

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male participants were eligible to participate in the study. Gender identity was not a restriction, but biological sex was considered for eligibility.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, untrained individuals (no prior structured resistance training experience for at least 6 months).
  • Aged between 18-25 years old.
  • No current or recent musculoskeletal injuries affecting exercise performance.
  • No diagnosed medical conditions that could interfere with resistance training.
  • Willing to participate in an 8-week structured resistance training program.
  • No use of performance-enhancing drugs, anabolic steroids, or other muscle-growth supplements.

You may not qualify if:

  • Individuals with prior resistance training experience within the last 6 months.
  • Any current or past musculoskeletal injuries or conditions affecting the lower or upper limbs.
  • Any diagnosed metabolic, cardiovascular, or neurological disorders that could affect physical performance.
  • Individuals currently taking medications that affect muscle function or recovery.
  • Pregnant or breastfeeding individuals.
  • Failure to comply with the study protocol (e.g., missing more than 2 training sessions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University, Faculty of Sport Sciences

Gaziantep, Şehitkamil, 27350, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Zarife Pancar Assistant Professor,, PhD

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
This study utilized a double-blind (participant and outcomes assessor) design to minimize bias in the evaluation of muscle hypertrophy and strength. Participants were unaware of which limb was assigned to the deload or continuous training condition to prevent psychological or behavioral influences on training performance. The outcomes assessor conducting muscle thickness measurements (using B-mode ultrasound) and strength assessments (10RM test) was blinded to the condition assignments to ensure unbiased data collection. The researchers responsible for training supervision were aware of the limb assignments but did not participate in the measurement or data analysis process. This blinding method was implemented to enhance the validity of the study and reduce potential bias in both subjective and objective outcome measures.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study utilizes a crossover within-subject design, where each participant's limbs were assigned to two different training conditions: Deload Training Condition: Training volume and frequency were reduced for one week every four weeks. Continuous Training Condition: Training continued without volume reduction. Each participant performed unilateral leg extension and dumbbell biceps curl exercises twice per week for 8 weeks. One limb was assigned to the deload condition, while the other was assigned to the continuous training condition. This within-subject design was chosen to minimize inter-individual variability and enhance statistical power. Muscle hypertrophy and strength were assessed before and after the intervention using B-mode ultrasound and 10-repetition maximum (10RM) testing, respectively.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor,

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 13, 2025

Study Start

May 1, 2024

Primary Completion

June 25, 2024

Study Completion

August 20, 2024

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared with other researchers upon reasonable request. Data will be available after study completion and publication, following ethical approval and data-sharing agreements. Researchers interested in accessing the data may contact the corresponding author.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
De-identified individual participant data (IPD), along with the study protocol and statistical analysis plan, will be made available upon request after study completion and publication. Researchers interested in accessing the data should contact the corresponding author. Data will be shared under a data-sharing agreement to ensure compliance with ethical and privacy guidelines.
Access Criteria
De-identified individual participant data (IPD) and supporting documents, including the study protocol and statistical analysis plan, will be available upon reasonable request for research purposes. Access will be granted to qualified researchers affiliated with academic or research institutions. Researchers must submit a data-sharing request, including a brief study proposal outlining their intended use of the data. All data-sharing requests will be reviewed by the study team, and approved researchers must sign a data-sharing agreement to ensure compliance with ethical and privacy guidelines. Data will be shared in a secure format via institutional data-sharing platforms or encrypted file transfer.
More information

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