Upper Versus Lower Body Resistance Exercise in Older Adults

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831373
• Other study ID #: 16-1009-17
• Status: Completed
• Phase: N/A
• Start date: February 21, 2018
• Est. completion date: March 21, 2019

Study information

• Verified date: April 2019
• Source: University of Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Aging
• Quality of Life

Intervention

Other:
• Physical exercise
Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.

Locations

Country	Name	City	State
Spain	DomusVi Barreiro	Vigo	Galicia

Sponsors (1)

Lead Sponsor	Collaborator
University of Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spanish version of the Mini-Mental State Examination.	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
Primary	Test of the pictures	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
Primary	Trail Making Test part A.	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
Primary	Timed Up and Go Test	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
Primary	Grip Strength	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
Primary	Chair Sit and Reach	Present in the Senior Fitness Test, to assess the mobility/flexibility of the lower back and limbs.	24 weeks
Primary	Back Scratch Test	Present in the Senior Fitness Test, this evaluates the joint mobility of the shoulders.	24 weeks