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Improving Muscle Strength, Mass and Physical Function in Older Adults

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ClinicalTrials.gov Identifier: NCT03297632
Recruitment Status : Unknown
Verified October 2018 by Anna Nordström, Västerbotten County Council.
Recruitment status was:  Enrolling by invitation
First Posted : September 29, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Anna Nordström, Västerbotten County Council

Brief Summary:
Falls and fractures are serious and costly events for elderly individuals: they cause functional impairments, increase mortality and contribute to huge healthcare costs for the society. The number of falls, and following consequences, are expected to increase in society as the proportion of the elderly population will increase, therefore it is crucial to be able to detect and prevent falls and fractures in the population. The investigators have previously published results that objective measurements of postural balance can predict fall risk in 70-year-olds in Umeå and subsequently investigated whether balance can be improved through 4-week balance exercise program. However, preliminary results suggest that the frequency and duration of exercise should be longer than 3 times a week for 4 weeks to produce effects. Furthermore, there is also evidence indicating a link between muscle weakness and fall risk in elderly subjects, while research findings show that it is possible for older individuals to influence muscle strength and muscle mass with resistance exercise. Functional strength training can also positively influence the balance. In this context, the investigators aim to investigate whether a 10-week resistance exercise program may positively affect balance, muscle strength, muscle mass and physical function, with the aim of preventing future falls and fractures in the population.

Condition or disease Intervention/treatment Phase
Muscle Weakness Fall Sarcopenia Behavioral: Functional resistance exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Functionally Designed Resistance Exercise With the Aim of Improving Balance, Muscle Strength, Muscle Mass and Physical Function of the Elderly: a Randomized Controlled Study
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Receives instructor-based functional resistance exercise. 45 minutes per session. 3 times per week, during 10 weeks in total.
Behavioral: Functional resistance exercise
Functional resistance program designed for older individuals with low muscle mass and muscle strength. The goal is to implement exercises that are possible for the participants to also perform in their home environment, through the use of basic equipment.

No Intervention: Control group
Asked to normally active according to their current lifestyle
Active Comparator: Home-based group
Receives home-based exercises with written instructions and digital video support. 45 minutes per session. 3 times per week, during 10 weeks in total.
Behavioral: Functional resistance exercise
Functional resistance program designed for older individuals with low muscle mass and muscle strength. The goal is to implement exercises that are possible for the participants to also perform in their home environment, through the use of basic equipment.




Primary Outcome Measures :
  1. Change in Postural Stability performance [ Time Frame: Change in Postural Stability performance at 10 and 34 weeks ]
    Postural stability measurement task from the Short Physical Performance Battery (SPPB), containing bipedal, semi-tandem and tandem stances. Measured in seconds, up to a maximal value of 10 seconds.

  2. Change in Gait Speed [ Time Frame: Change in Gait Speed at 10 and 34 weeks ]
    Gait speed measurement task from the Short Physical Performance Battery (SPPB). Measured in the seconds it takes to walk 4 meters.

  3. Change in Chair Stand performance [ Time Frame: Change in Chair stand performance at 10 and 34 weeks ]
    Chair stand measurement task from the Short Physical Performance Battery (SPPB). Measures in the time it takes to stand up 5 times.


Secondary Outcome Measures :
  1. Change in Postural Sway [ Time Frame: Change in Baseline Postural Sway at 10 and 34 weeks ]
    Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each

  2. Change in Isometric Muscle Strength [ Time Frame: Change in Baseline Isometric Muscle Strength at 10 and 34 weeks ]
    Measured by using a hydraulic hand dynamometer. The maximum value obtained in two consecutive attempts is recorded.

  3. Change in Appendicular Muscle Mass [ Time Frame: Change in Baseline Appendicular Muscle Mass at 10 and 34 weeks ]
    Measured with a iDXA device. Measurements are based on whole-body scans with a duration of approximately 8 minutes.

  4. Change in TUG test performance [ Time Frame: Change in Baseline TUG test performance at 10 and 34 weeks ]
    The Timed-Up-and-Go test is commonly used by clinicians to assess lower leg muscle strength, gait performance, and overall functional mobility in elderly individuals

  5. Change in Physical Activity [ Time Frame: Change in Baseline Physical Activity at 10 and 34 weeks ]
    Objective measures through the use of triaxial accelerometers

  6. Change in Fear of Falling [ Time Frame: Change in Baseline Fear of Falling at 10 and 34 weeks ]
    Assessed with the validated Falls Efficacy Scale-International questionnaire

  7. Change in self-recalled Physical Activity [ Time Frame: Change in Baseline self-recalled Physical Activity at 10 and 34 weeks ]
    Assessed with the validated International Physical Activity Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 70 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the Healthy Ageing Initiative (HAI) study
  • Appendicular lean mass index in the lowest 20% measured with the iDXA in the HAI study, separate for men and women.

Exclusion Criteria:

  • Unable to be present during all 10 weeks of exercise.

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): NCT03297632


Locations
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Sweden
Livsmedicin (LIFE)
Umeå, Västerbotten, Sweden, 907 36
Sponsors and Collaborators
Västerbotten County Council
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Nordström, Adjunct Professor, Västerbotten County Council
ClinicalTrials.gov Identifier: NCT03297632    
Other Study ID Numbers: VCC-LIFE-3
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes