NCT04053920

Brief Summary

The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

August 9, 2019

Last Update Submit

March 24, 2020

Conditions

SarcopeniaFrailtyAging

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    Knee extensor maximal torque during an isometric MVC

    Change from baseline to 8 weeks

Secondary Outcomes (6)

  • Vastus lateralis muscle thickness

    Change from baseline to 8 weeks

  • Muscle strength

    Change from baseline to 8 weeks

  • One-repetition maximum

    Change from baseline to 8 weeks

  • Biomechanics during walking and stair climbing

    Change from baseline to 8 weeks

  • Short performance physical battery test

    Change from baseline to 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Low load

EXPERIMENTAL

Training at 30-40% one-repetition maximum (1RM)

Behavioral: Low Load Resistance exercise

High load

EXPERIMENTAL

Training at 65-75% one-repetition maximum (1RM)

Behavioral: High Load Resistance exercise

Interventions

Low Load Resistance exerciseBEHAVIORAL

leg extension, leg press, leg curl and calf press

Low load
High Load Resistance exerciseBEHAVIORAL

leg extension, leg press, leg curl and calf press

High load

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Over age of 65 years

You may not qualify if:

  • Current participation in an exercise programme
  • Exercise deemed unsafe by clinical team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GRI Clinical Research Facility

Glasgow, G12 8TA, United Kingdom

Location

MeSH Terms

Conditions

SarcopeniaFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Stuart Gray

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Exercise and Metabolic Health

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 13, 2019

Study Start

March 1, 2018

Primary Completion

December 18, 2019

Study Completion

December 18, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)