- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03831373
Upper Versus Lower Body Resistance Exercise in Older Adults
Effects of Resistance Exercise Focused on the Upper Body Versus the Lower Body on Global Physical Fitness and Cognitive Status of Older Adults Living in Geriatric Centers
TITLE: Relation between focused resistance training and its effect on cognitive performance and functional Independence of institutionalized elderly.
HIPOTHESIS: The performance of a physical exercise program based on resistance training in older adults stabilizes or improves some parameters of the functional independence as well as the cognitive function, finding effects overall organism by the focused training of some muscular groups.
GENERAL OBJECTIVES: 1) to analyze the differential effects of an exercise program based on the training of the muscular strength of the upper body versus a lower body one, at short and long term in institutionalized elderly people; 2) to identify if there is any relations between the variables that induce frailness or functional dependence and the physical exercise program.
SPECIFIC OBJECTIVES: To determine the differential effects of a physical exercise program based on the development of the muscular strength of the upper body versus the lower body, in sessions of 40 minutes a day, 2 days per week during 7 months on: a) The improvement of functional independence by the amelioration of balance, decrease of fall risk and an adequate development in the activities of daily living; b) The improvement of the global cognitive function; c) The improvement of the quality of life.
METHODS
- Design: Controlled trial. The institutionalized elderly from the geriatric centers will be invited to take part in the study. After they meet the selection criteria, they will be assigned to two experimental groups and one control group in each center. Information regarding sociodemographic characteristics and a clinical anamnesis of the participants will be collected.
- Intervention: Three groups, one from each centre. Two centers, experimental groups, will perform two physical exercises programs of resistance training with elastic bands, one focused on the upper and one on the lower body. They will be carried 2 days per week, during 3 months in 45-minute sessions. The program will consist of 5 exercises, with a volume of 4 sets of 12 repetitions, with 2-minute breaks between sets and 3 between exercises. Control group will participate in 40 minutes stretching sessions, 3 times per week. After 3 months of exercise and after three months of transition, they experimental groups will perform the other program for another 3 months, crossing the interventions.
- Assessments: Six will be carried: At the beginning, at the end of the first intervention, at the beginning of the second one, at the end and a follow up 3 months later. In each, it will be assessed the potential cognitive impairment and cognitive status (Spanish version of the MMSE, Fototest and Trail Making Test part A), functional independence (Timed Up and Go Test), grip strength (hand dynamometer), lower body strength (30 Seconds Chair Stands) and flexibility/mobility (Chair Sit-and-Reach and Back Scratch Test.)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Galicia
-
Vigo, Galicia, Spain, 362014
- DomusVi Barreiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No medical contraindications to be involved in the exercise programs.
- To be able to follow the exercise classes
- Signed informed consent
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Upper-limb-focused resistance training
|
Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.
|
Experimental: Lower-limb-focused resistance training
Lower-limb-focused resistance training with elastic bands.
|
Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.
|
Active Comparator: Stretching exercise
Stretching exercise program in a sitting position.
|
Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spanish version of the Mini-Mental State Examination.
Time Frame: 24 weeks
|
The Mini-Mental State Examination is a 30-point questionnaire comprised by eight different categories and score range.
Orientation to time (0-5 points) Orientation to place (0-5 points) Registration (0-3 points) Attention and calculation (0-5 points) Recall (0-3 points) Language (0-2 points) Repetition (0-1 points) Complex commands (0-6 points).
Interpretation: Any score greater than or equal to 24 points (out of 30) indicates a normal cognition.
≤9 points: severe cognitive impairment 10-18 points: moderate cognitive impairment and 19-23 points: mild cognitive impairment.
|
24 weeks
|
Test of the pictures
Time Frame: 24 weeks
|
The test of the pictures (Fototest in the Spanish version) is used to assess the short and long-term memory, the verbal fluency and denomination capacities.
The test is well correlated with the Mini-mental State Examination and it's reference values are situated in 34.4±4.4.
|
24 weeks
|
Trail Making Test part A.
Time Frame: 24 weeks
|
The Trail Making Test part A. The time required by an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper is measured.
|
24 weeks
|
Timed Up and Go Test
Time Frame: 24 weeks
|
Standardized test to assess the basic functional mobility of elderly persons.
The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
|
24 weeks
|
Grip Strength
Time Frame: 24 weeks
|
Assessed by means of a hand-held dynamometer, Grip Strength: By means of a hand-held dynamometer, this assessment has been stated as a predictor of frailty and mortality.
|
24 weeks
|
Chair Sit and Reach
Time Frame: 24 weeks
|
Present in the Senior Fitness Test, to assess the mobility/flexibility of the lower back and limbs.
|
24 weeks
|
Back Scratch Test
Time Frame: 24 weeks
|
Present in the Senior Fitness Test, this evaluates the joint mobility of the shoulders.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16-1009-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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