NCT06727695

Brief Summary

This study aims to evaluate the effectiveness of Technogyms BioStrength equipment compared to traditional strength training equipment over a 12-week intervention period. The study will determine whether BioStrength machines produce more effective results in terms of muscle strength and body composition. Participants will be allocated to either the BioStrength group or the traditional training group using a minimisation technique to balance important prognostic factors such as handgrip strength, age and gender between the groups. Key measurements include maximum strength tests (10RM) for leg press and chest press, handgrip strength using a dynamometer, and body composition using bioimpedance analysis. Circumference measurements will also be taken. The study will assess whether BioStrength equipment provides superior results in muscle strength, body composition and training efficiency compared to conventional gym equipment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 30, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

October 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 11, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

September 30, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

Strength trainingMuscle strengthBody compositionCustomer satisfactionBioStrengthTechnogymResistance trainingFitness equipmentHandgrip strengthRandomized controlled trial

Outcome Measures

Primary Outcomes (4)

  • Change in Skeletal Muscle Mass

    Skeletal muscle mass will be measured using bioimpedance analysis (BIA) at baseline and after the 12-week intervention to evaluate changes in muscle mass.

    Baseline and Week 12

  • Change in Body Fat Percentage

    Body fat percentage will be measured using bioimpedance analysis (BIA) at baseline and after the 12-week intervention to assess reductions in body fat.

    Baseline and Week 12

  • Change in Handgrip Strength

    Handgrip strength will be measured using a Jamar dynamometer, with measurements taken at baseline and after the 12-week intervention.

    Baseline and Week 12

  • Change in Maximal Strength (10-RM Test)

    Maximal strength will be measured using the 10-RM (Repetition Maximum) test for the leg press and chest press exercises at baseline and after the 12-week intervention.

    Baseline and Week 12

Secondary Outcomes (2)

  • Customer Satisfaction (CSAT Questionnaire)

    Week 2 and Week 12

  • Change in Circumference Measurements (Arm, Leg, and Waist)

    Baseline and Week 12

Study Arms (2)

Control Group (No BioStrength Training)

ACTIVE COMPARATOR

Participants in the Active Comparator group will undergo a conventional strength training program using standard gym machines. Training sessions will occur 3 times per week for 12 weeks. The goal is to compare the outcomes of BioStrength training with traditional strength training.

Device: Conventional training

BioStrength training

EXPERIMENTAL

Participants in the Intervention Group will undergo BioStrength training using Technogym equipment. The intervention will last for 12 weeks, with sessions conducted 3 times per week

Device: BioStrength Intervention

Interventions

Participants in the Intervention Group will undergo BioStrength training using Technogym equipment. The intervention will last for 12 weeks, with sessions conducted 3 times per week

BioStrength training

Participants in the Active Comparator group will undergo a conventional strength training program using standard gym machines. Training sessions will occur 3 times per week for 12 weeks. The goal is to compare the outcomes of BioStrength training with traditional strength training.

Control Group (No BioStrength Training)

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30 and 65 years
  • Healthy individuals without significant medical conditions
  • Less than 6 months of prior strength training experience
  • Willing and able to participate in a 12-week training program
  • Capable of performing strength training exercises such as leg press and chest press
  • Able to provide written informed consent

You may not qualify if:

  • History of coronary heart disease
  • History of stroke
  • Need for changes in antihypertensive treatment within 3 months prior to study start
  • Arthritis
  • Pregnancy or less than three months postpartum
  • Pain and movement restrictions
  • Use of medications that affect muscle strength or performance (e.g., anabolic steroids, beta-2 agonists, glucocorticoids, statins, benzodiazepines, ACE inhibitors, angiotensin-II receptor blockers, diuretics)
  • Any medical condition preventing participation in planned endurance and strength training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CF Leibnitz

Leibnitz, Styria, Styria, 8430, Austria

RECRUITING

MeSH Terms

Conditions

Consumer Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Martin Atia

    University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2024

First Posted

December 11, 2024

Study Start

October 8, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

December 11, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

The individual participant data (IPD) used in the published results will be shared in an anonymized format. Access will be provided upon request through a secure data repository for researchers who meet the criteria for access to confidential data

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon publication for one year

Locations