Clinical trial NCT03627793: Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
Official title: Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: frailty
exercise
resistance training
strength
older adults
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2018-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

Detailed description: The cohort will comprise two sets of participants: frail older adults and non-frail older adults.

Each participant will receive 8 weeks of twice weekly supervised resistance training. Both the frail and non-frail participants will be randomised into either receiving high load resistance training or low load resistance training. High load resistance training will be delivered at 70% of the participants maximal capacity and low load resistance training will be delivered at 30% of maximal capacity. All resistance training will focus on the lower limb and regardless of intensity each exercise will be done to failure (unable to complete another full repetition).

Eligibility criteria: Inclusion Criteria:

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%.

Exclusion Criteria:

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.

Primary outcomes:
measure: Number of training sessions attended
timeFrame: 8 weeks
measure: Compliance with protocol
timeFrame: 8 weeks
measure: Number of treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 8 weeks
measure: Acceptability of intervention (qualitative)
timeFrame: 8 weeks
Secondary outcomes:
measure: Muscle thickness
timeFrame: 8 weeks
measure: Muscle power
timeFrame: 8 weeks
measure: Muscle strength
timeFrame: 8 weeks
measure: Frailty
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
measure: Activities of daily living
timeFrame: 8 weeks
measure: Activities of daily living
timeFrame: 8 weeks
measure: Functional abilities
timeFrame: 8 weeks
measure: motion analysis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
Study officials:
affiliation: Univeristy of Glasgow
name: Evan Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: