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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03297632
Other study ID # VCC-LIFE-3
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 4, 2017
Est. completion date November 30, 2019

Study information

Verified date October 2018
Source Västerbotten County Council
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Livsmedicin (LIFE) Umeå Västerbotten

Sponsors (1)

Lead Sponsor Collaborator
Västerbotten County Council

Country where clinical trial is conducted

Sweden, 

References & Publications (22)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in Postural Stability performance 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. Change in Postural Stability performance at 10 and 34 weeks
Primary Change in Gait Speed Gait speed measurement task from the Short Physical Performance Battery (SPPB). Measured in the seconds it takes to walk 4 meters. Change in Gait Speed at 10 and 34 weeks
Primary Change in Chair Stand performance Chair stand measurement task from the Short Physical Performance Battery (SPPB). Measures in the time it takes to stand up 5 times. Change in Chair stand performance at 10 and 34 weeks
Secondary Change in Postural Sway Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each Change in Baseline Postural Sway at 10 and 34 weeks
Secondary Change in Isometric Muscle Strength Measured by using a hydraulic hand dynamometer. The maximum value obtained in two consecutive attempts is recorded. Change in Baseline Isometric Muscle Strength at 10 and 34 weeks
Secondary Change in Appendicular Muscle Mass Measured with a iDXA device. Measurements are based on whole-body scans with a duration of approximately 8 minutes. Change in Baseline Appendicular Muscle Mass at 10 and 34 weeks
Secondary Change in TUG test performance 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 Change in Baseline TUG test performance at 10 and 34 weeks
Secondary Change in Physical Activity Objective measures through the use of triaxial accelerometers Change in Baseline Physical Activity at 10 and 34 weeks
Secondary Change in Fear of Falling Assessed with the validated Falls Efficacy Scale-International questionnaire Change in Baseline Fear of Falling at 10 and 34 weeks
Secondary Change in self-recalled Physical Activity Assessed with the validated International Physical Activity Questionnaire Change in Baseline self-recalled Physical Activity at 10 and 34 weeks
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