NCT03831373

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.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

October 9, 2018

Last Update Submit

April 16, 2019

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Chair Sit and Reach

    Present in the Senior Fitness Test, to assess the mobility/flexibility of the lower back and limbs.

    24 weeks

  • Back Scratch Test

    Present in the Senior Fitness Test, this evaluates the joint mobility of the shoulders.

    24 weeks

Study Arms (3)

Upper-limb-focused resistance training

EXPERIMENTAL
Other: Physical exercise

Lower-limb-focused resistance training

EXPERIMENTAL

Lower-limb-focused resistance training with elastic bands.

Other: Physical exercise

Stretching exercise

ACTIVE COMPARATOR

Stretching exercise program in a sitting position.

Other: Physical exercise

Interventions

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

Lower-limb-focused resistance trainingStretching exerciseUpper-limb-focused resistance training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No medical contraindications to be involved in the exercise programs.
  • To be able to follow the exercise classes
  • Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DomusVi Barreiro

Vigo, Galicia, 362014, Spain

Location

Related Publications (1)

  • Sanchez-Lastra MA, Varela S, Cancela JM, Ayan C. Upper versus lower body resistance exercise with elastic bands: effects on cognitive and physical function of institutionalized older adults. Eur Geriatr Med. 2022 Aug;13(4):907-916. doi: 10.1007/s41999-022-00616-6. Epub 2022 Feb 12.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

February 5, 2019

Study Start

February 21, 2018

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations