NCT03690258

Brief Summary

The primary aim of this research proposal is to examine whether this novel training program approach is capable to tackle excessive loss in muscle mass, function and contractile capacity with aging. Previous investigations have universally shown a dramatic loss in type II muscle fibers, while certain countermeasures in their follow-up studies were generally ineffective and limited to attenuate this phenomenon. Probably, they failed to meet recruitment threshold of larger motor units and subsequently innervate type II muscle fibers. Furthermore, previous investigations also failed to provide any data on specific blood markers that may provide additional insight into muscle fiber loss with aging. Muscle fibers type II play a crucial role in the human ability to produce as much as force as possible over a limited time-frame (e.g. 100-200 ms) to counteract unexpected perturbations during stair climbing for example and thus avoiding falls. Therefore, this data collection would be noteworthy in particular, especially for this population due to health-related outcomes and healthy aging process. Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, data collected may aid in development of safety guidelines and protocols aimed at reducing health risks in this specific population. Importantly, in case the aforementioned hypotheses are confirmed, present findings may offer important information to the healthcare system, especially for reducing economic burden.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 25, 2018

Last Update Submit

September 25, 2019

Conditions

Keywords

muscle function; muscle fibers; systolic blood pressure

Outcome Measures

Primary Outcomes (2)

  • Continuous blood pressure monitoring via photopletismograpy (via Finometer) and non-invasive hemodynamics assessment

    Non-pharmacological intervention (exercise intervention); To address motor unit recruitment pattern with pre-post intervention data collection scheme.

    12-24 months

  • Non invasive surface electromyography (HD EMG, in mV) during MVC (maximal voluntary contraction, Nm), Peak oxygen uptake assessment (VO2; ml kg min-1)

    Pulmonary ventilation and oxygen uptake at rest and during cycling. All data will be collected via a portable system (K5 RQ, Cosmed, Rome, Italy)

    12-24 months

Secondary Outcomes (1)

  • Endothelial function (via non invasive flow mediated dilatation technique

    12-24 months

Study Arms (2)

Variable load exercise

EXPERIMENTAL

Variable load intervention (The nHANCE-squat ultimate - iso-inertial load, with power output in watts performed 3 x per week) will being performed to determine whether this training approach is an effective countermeasure to attenuate for rapid declines in muscle power, function, contractile capacity that typically originate from aging and muscle disuse. Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, we could develop safety guidelines and protocols aimed at reducing health risks in seniors. Data available at: http://nhance.se/

Device: Variable load exercise

Variable load intervention

EXPERIMENTAL

This study is being conducted to determine whether this variable load (The nHANC dead lift - eccentric overload performed 3 x per week for 4-6 weeks) intervention is an effective countermeasure to modulate blood pressure in seniors. Since age-related incline in resting blood pressure (hypertension) is accelerated already after short bouts of physical inactivity, any attempt to counteract age-related and disuse-related decline have high clinical significance. In addition, we aim to examine endothelial function via non-invasive flow mediated dilatation (FMD) technique. Based on the findings, we could develop safety guidelines and protocols aimed at reducing health risks in this specific population. Importantly, in case present hypotheses are confirmed, this may offer important information to the healthcare system, especially for reducing economic burden.

Device: Variable load exercise

Interventions

This study is being conducted to determine whether variable load training approach (nHANCE™ squat - more data available at http://nhance.se/) is an effective countermeasure to attenuate for rapid declines in muscle power, function, that typically originate from aging and muscle disuse. Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, safety guidelines and protocols could be developed aimed at reducing health risks in seniors. Importantly, in case present hypotheses are confirmed, this may offer important information to the healthcare system.

Variable load exerciseVariable load intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders will be included;
  • signed informed consent and doctor's permission;
  • Age \>50 years;
  • BMI \<30 kg/m2,
  • At least 30 minutes of daily moderate-to-vigorous physical activity during (including five days of monitoring prior to any data collection).

You may not qualify if:

  • Severe cardiovascular diseases;
  • hypertension prevalence (\>140/90 mm Hg).
  • history of severe musculoskeletal and neurological disorders/injuries;
  • history of severe neurological disorders;
  • supplement or drug consumption that may interfere with training outcomes;
  • alcohol consumption and smoking;
  • use of walking aids;
  • Data collection risks include potential transient discomfort from the venipuncture blood sampling and muscle soreness originating from experimental training protocols. The participants will get valuable information on how their muscles adapt following systematic training protocols.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Primorska

Koper, 6000, Slovenia

NOT YET RECRUITING

ZRS Koper

Koper, 6000, Slovenia

RECRUITING

Related Publications (1)

  • Zubac D, Obad A, Ivancev V, Valic Z. Acute flywheel exercise does not impair the brachial artery vasodilation in healthy men of varying aerobic fitness. Blood Press Monit. 2021 Jun 1;26(3):215-223. doi: 10.1097/MBP.0000000000000523.

Related Links

MeSH Terms

Conditions

SarcopeniaHypertensionMuscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Rado Pisot, PhD

    Science and Research Center Koper, Institute for Kinesiology Research

    STUDY DIRECTOR

Central Study Contacts

Patricia Kompara, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Researches collecting data will be blinded of participant allocation.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Variable load exercise, non-pharmacological intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 1, 2018

Study Start

July 5, 2019

Primary Completion

March 30, 2020

Study Completion

July 30, 2020

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations