Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study

Frail Elderly Syndrome Clinical Trial

Official title:

Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03627793
• Other study ID #: 3.0
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: November 29, 2019

Study information

• Verified date: October 2018
• Source: University of Glasgow
• Contact: Evan Campbell, PhD
• Phone: 0141 330 3076
• Email: campbell.evan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

Other:
• resistance training
Moving muscles against loads with the purpose of increasing strength.

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of training sessions attended	Expressed as a percentage of number of sessions attended	8 weeks
Primary	Compliance with protocol	Expressed as a percentage of number of sessions where training protocol was adhered to	8 weeks
Primary	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
Primary	Acceptability of intervention (qualitative)	focus groups with semi-structured discussion plans will investigate the acceptability of the intervention	8 weeks
Secondary	Muscle thickness	Thickness of vastus lateralus using ultrasound (mm)	8 weeks
Secondary	Muscle power	Maximum voluntary contraction of a muscle at a set angle to produce a torque (kg)	8 weeks
Secondary	Muscle strength	Maximal load participant can lift (kg)	8 weeks
Secondary	Frailty	As measured by the Fried criteria. These are low energy expenditure, slow gait speed, weak grip strength, exhaustion, and unintentional weight loss. Fulfilling three of these criteria indicates clinical frailty.	8 weeks
Secondary	Quality of life	Measured using the Euroqol EQ-5 Dimension- 5 Level self report measure. This scale measures quality of life in 5 dimensions and produces an index of quality of life rangin from a worst quality of life at -1 to best quality of life at 1.	8 weeks
Secondary	Activities of daily living	Measured using the Barthel index. This scale measures ten variables of activities of daily living and produces an overall score. This ranges from 0-20 with a higher score indicating greater independence.	8 weeks
Secondary	Activities of daily living	Measured using the Lawton ADL scale. this self report measures assess independence in daily living in 8 different domains but produces an overall score. Scores range from 0-8 with 8 indicating full independence.	8 weeks
Secondary	Functional abilities	Short performance battery test. This battery of tests assesses balance, gait speed and lower limb strength. Scores are awarded for each individual section and aggregated ranging from 0-12 with a higher score indicating greater physical capability.	8 weeks
Secondary	motion analysis	biomechanical assessment using infr-red motion analysis cameras	8 weeks