Upper Versus Lower Body Resistance Exercise in Older Adults

• ClinicalTrials.gov Identifier: NCT03831373
• Recruitment Status: Completed
• First Posted: February 5, 2019
• Last Update Posted: April 17, 2019
• Sponsor: University of Vigo
• Information provided by (Responsible Party): Miguel A. Sánchez-Lastra, University of Vigo

Study Description

Brief 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.)

Condition or disease	Intervention/treatment	Phase
Quality of Life; Aging	Other: Physical exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• 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
• Actual Study Start Date: February 21, 2018
• Actual Primary Completion Date: March 21, 2019
• Actual Study Completion Date: March 21, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Upper-limb-focused resistance training	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.
Experimental: Lower-limb-focused resistance training; Lower-limb-focused resistance training with elastic bands.	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.
Active Comparator: Stretching exercise; Stretching exercise program in a sitting position.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Back Scratch Test [ Time Frame: 24 weeks ]
   Present in the Senior Fitness Test, this evaluates the joint mobility of the shoulders.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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:

-

Contacts and Locations

Locations

Spain

DomusVi Barreiro

Vigo, Galicia, Spain, 362014

Sponsors and Collaborators

University of Vigo

More Information

• Responsible Party: Miguel A. Sánchez-Lastra, Principal Investigator, University of Vigo
• ClinicalTrials.gov Identifier: NCT03831373
• Other Study ID Numbers: 16-1009-17
• First Posted: February 5, 2019
• Last Update Posted: April 17, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miguel A. Sánchez-Lastra, University of Vigo:

Exercise