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

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ClinicalTrials.gov Identifier: NCT03627793
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Dr Evan Campbell, University of Glasgow

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.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Other: resistance training Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
Actual Study Start Date : August 21, 2018
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : November 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High load non-frail
Non-frail participants who will receive resistance training at 70% of their maximal strength
Other: resistance training
Moving muscles against loads with the purpose of increasing strength.

Active Comparator: low load non-frail
Non-frail participants who will receive resistance training at 30% of their maximal strength
Other: resistance training
Moving muscles against loads with the purpose of increasing strength.

Experimental: high load frail
Frail participants who will receive resistance training at 70% of their maximal strength
Other: resistance training
Moving muscles against loads with the purpose of increasing strength.

Experimental: low load frail
Frail participants who will receive resistance training at 30% of their maximal strength
Other: resistance training
Moving muscles against loads with the purpose of increasing strength.




Primary Outcome Measures :
  1. Number of training sessions attended [ Time Frame: 8 weeks ]
    Expressed as a percentage of number of sessions attended

  2. Compliance with protocol [ Time Frame: 8 weeks ]
    Expressed as a percentage of number of sessions where training protocol was adhered to

  3. Number of treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 8 weeks ]
    Number of adverse events that could be attributed to the intervention

  4. Acceptability of intervention (qualitative) [ Time Frame: 8 weeks ]
    focus groups with semi-structured discussion plans will investigate the acceptability of the intervention


Secondary Outcome Measures :
  1. Muscle thickness [ Time Frame: 8 weeks ]
    Thickness of vastus lateralus using ultrasound (mm)

  2. Muscle power [ Time Frame: 8 weeks ]
    Maximum voluntary contraction of a muscle at a set angle to produce a torque (kg)

  3. Muscle strength [ Time Frame: 8 weeks ]
    Maximal load participant can lift (kg)

  4. Frailty [ Time Frame: 8 weeks ]
    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.

  5. Quality of life [ Time Frame: 8 weeks ]
    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.

  6. Activities of daily living [ Time Frame: 8 weeks ]
    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.

  7. Activities of daily living [ Time Frame: 8 weeks ]
    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. Functional abilities [ Time Frame: 8 weeks ]
    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.

  9. motion analysis [ Time Frame: 8 weeks ]
    biomechanical assessment using infr-red motion analysis cameras



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627793


Contacts
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Contact: Evan Campbell, PhD 0141 330 3076 campbell.evan@gmail.com

Locations
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United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom
Contact: Evan Campbell, PhD    0141 330 3076    evan.campbell@glasgow.ac.uk   
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde
Investigators
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Principal Investigator: Evan Campbell, PhD Univeristy of Glasgow
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Responsible Party: Dr Evan Campbell, Research Associate, University of Glasgow
ClinicalTrials.gov Identifier: NCT03627793    
Other Study ID Numbers: 3.0
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Evan Campbell, University of Glasgow:
frailty
exercise
resistance training
strength
older adults