Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
1 active site
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
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2019
CompletedOctober 11, 2018
October 1, 2018
1.3 years
August 2, 2018
October 9, 2018
Conditions
Keywords
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 COMPARATORNon-frail participants who will receive resistance training at 70% of their maximal strength
low load non-frail
ACTIVE COMPARATORNon-frail participants who will receive resistance training at 30% of their maximal strength
high load frail
EXPERIMENTALFrail participants who will receive resistance training at 70% of their maximal strength
low load frail
EXPERIMENTALFrail participants who will receive resistance training at 30% of their maximal strength
Interventions
Moving muscles against loads with the purpose of increasing strength.
Eligibility Criteria
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
- University of Glasgowlead
- NHS Greater Glasgow and Clydecollaborator
Study Sites (1)
Glasgow Royal Infirmary
Glasgow, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Campbell, PhD
Univeristy of Glasgow
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
- 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