NCT03627793

Brief Summary

After the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. It is known that, across the life course, resistance exercise can be of benefit in increasing muscle mass and function, yet how hard the exercise should be performed has received little attention. Current recommendations are for older people to perform exercise at 70% of the maximum they can lift, quite a high intensity that often puts older people off participating. Recent evidence in younger people has suggested that such intensities are not required. The investigators aim to determine the feasibility of a study to investigate recruitment and adherence of older people to a study of exercise training at different intensities.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

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

August 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

August 2, 2018

Last Update Submit

October 9, 2018

Conditions

Keywords

frailtyexerciseresistance trainingstrengtholder adults

Outcome Measures

Primary Outcomes (4)

  • Number of training sessions attended

    Expressed as a percentage of number of sessions attended

    8 weeks

  • Compliance with protocol

    Expressed as a percentage of number of sessions where training protocol was adhered to

    8 weeks

  • Number of treatment-related adverse events as assessed by CTCAE v4.0

    Number of adverse events that could be attributed to the intervention

    8 weeks

  • Acceptability of intervention (qualitative)

    focus groups with semi-structured discussion plans will investigate the acceptability of the intervention

    8 weeks

Secondary Outcomes (9)

  • Muscle thickness

    8 weeks

  • Muscle power

    8 weeks

  • Muscle strength

    8 weeks

  • Frailty

    8 weeks

  • Quality of life

    8 weeks

  • +4 more secondary outcomes

Study Arms (4)

High load non-frail

ACTIVE COMPARATOR

Non-frail participants who will receive resistance training at 70% of their maximal strength

Other: resistance training

low load non-frail

ACTIVE COMPARATOR

Non-frail participants who will receive resistance training at 30% of their maximal strength

Other: resistance training

high load frail

EXPERIMENTAL

Frail participants who will receive resistance training at 70% of their maximal strength

Other: resistance training

low load frail

EXPERIMENTAL

Frail participants who will receive resistance training at 30% of their maximal strength

Other: resistance training

Interventions

Moving muscles against loads with the purpose of increasing strength.

High load non-frailhigh load fraillow load fraillow load non-frail

Eligibility Criteria

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

You may qualify if:

  • Non-frail - Over 65 years of age Frail - Over 65 years of age, Three or more of the following criteria: \>10lbs of weight loss unintentionally in previous year; grip strength in lowest 20% (by sex and BMI); self-reported exhaustion; walking time for 15 feet in slowest 20% (by sex and height); physical activity in the lowest 20%.

You may not qualify if:

  • Non-frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.
  • Frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

FrailtyMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Evan Campbell, PhD

    Univeristy of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan Campbell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 13, 2018

Study Start

August 21, 2018

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations