CREM - Clinical and Functional Outcomes in a Controlled Clinical Trial with Older Adults

NCT06638697 | Not Yet Recruiting

• 1 other identifier: 36044620.5.0000.5336
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate and compare the effects of different types of physical exercise on clinical and functional outcomes in the elderly. 240 community-dwelling elderly individuals of both sexes, sedentary, will be recruited for twelve groups of elderly individuals who will receive intervention for 32 weeks of different types of physical exercise (free walking, Nordic walking, dancing, physical exercise for cognition, balance, aquatic physiotherapy, multicomponent gymnastics, water aerobics, hydro-postural exercises, aquatic jogging, weight training, and Pilates mat). The training programs will have a frequency of two sessions per week and will last 50 minutes and will be periodized so that the duration of the sessions is equal among them. In order to evaluate the effects of the training, evaluations will be carried out before, during and after the training period of functional fitness, clinical-functional and biomechanical parameters. It is expected that the intervention groups will present results according to the nature of the modality and that they will be more effective when compared to the control group. As well as improvements in the variables of gait speed, muscle strength, balance and cognition.

Conditions

Aged; Aged Subject

Keywords

elderly; functionality; physical exercise; cognition; physical fragility; physical fitness

Outcome Measures

Primary Outcomes (8)

• Lower Limb Strength

  Five-Repetition Sit-to-Stand Test - This assesses the time it takes for an individual to stand up so that their knees are fully extended and then sit down again as quickly as possible. Individuals with 5-repetition times for this test greater than the following may be considered to have poorer than average performance: 11.4 sec (60 to 69 years), 12.6 sec (70 to 79 years), and 14.8 sec (80 to 89 years).

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Upper limb strength

  Dynamometry - Obtained using a hand-held dynamometer. The subject is seated and asked to exert as much force as possible with the dominant upper limb. The highest strength value obtained will be considered, adjusted by the body mass index (in quartiles) and stratified by sex.

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Upper limb flexibility

  Reach Behind the Back - While standing, the subject places the preferred hand on the same shoulder, palm open and fingers extended, reaching as far as possible toward the middle of the back. The hand of the other arm is placed behind the back, palm up, reaching as far as possible, in an attempt to touch or overlap the extended middle fingers of the other hand. Measured in distance (cm).

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Lower limb flexibility

  Sitting and Reaching - The subject remains seated in the chair and with one leg extended, tries to reach the toes, it is measured in distance (cm).

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Aerobic endurance

  6-Minute Walk Test - On a 30-meter course, participants walk as fast as possible (without running) around the course as many times as they can within the time limit, it is measured in distance (m) and reflects aerobic endurance

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Static balance

  Single-leg support tests - Static balance tests (Single-leg 30 seconds). The ability of subjects to stand on the force platform in a single-leg position with their eyes open. The position is standing on one foot (single-leg support), the subject chooses whether the right or left leg, looking at a fixed point in line with the eyes. The task is timed until the subjects return the foot to the ground or reach the maximum time of 30 seconds. The force platform will be used and the rate of displacement of the COP will be analyzed in the anteroposterior (Fx), mediolateral (Fy) and vertical (Fz) axes.

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Dynamic balance

  Timed and Up and Go (TUG) - The patient starts by sitting in a chair, walks a distance of 3 meters, goes around a cone (180º turn), returns and sits back down in the chair. The patient is instructed to perform the test as quickly as possible. For classification: test performed in up to 10 seconds (healthy elderly, independent and without risk of falls); test between 11 and 20 seconds (frail elderly, with partial independence and low risk of falls); time greater than 20 seconds (significant deficit in physical capacity, high risk of falls and dependence in ADLs).

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Walking speed

  Ten-meter walk test - The ten-meter walk test will be used to assess self-selected walking speed (VAS). The time taken to walk ten meters will be recorded. The individual will be given the following command: "I want you to walk at a comfortable speed, the one that is most similar to your daily pace. The average time of three attempts will be used to calculate the walking speed expressed in meters per second (m/s).

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

Secondary Outcomes (4)

• Concern about falls

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Pain index

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Depressive symptoms

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

• Cognition

  Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).

Study Arms (1)

exercise program

EXPERIMENTAL

Participants will receive intervention of different physical training for 32 weeks and will be periodized in an equivalent way.

Other: Free walking; Other: Nordic walking; Other: Dance; Other: Physical exercise for cognition; Other: Balance; Other: Aquatic physiotherapy; Other: Multicomponent gymnastics; Other: Water aerobics; Other: Hydroposture; Other: deep water walking; Other: Weight training; Other: Mat pilates

Interventions

Free walking OTHER

The free walking training program will last 32 weeks. The intensity of the training will be controlled by the scale of perceived exertion (Borg). The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Nordic walking OTHER

The Nordic walking training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial and final stretching will last five minutes.

exercise program

Dance OTHER

The Dance training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial and final stretching will last five minutes.

exercise program

Physical exercise for cognition OTHER

The Physical exercise for cognition training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial and final stretching will last five minutes.

exercise program

Balance OTHER

The Balance training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial and final stretching will last five minutes.

exercise program

Aquatic physiotherapy OTHER

The Aquatic Physiotherapy training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Multicomponent gymnastics OTHER

The Multicomponent Gymnastics training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Water aerobics OTHER

The Water Aerobics training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Hydroposture OTHER

The Hydroposture training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

deep water walking OTHER

The deep water walking training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Weight training OTHER

The weight training program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Mat pilates OTHER

The MAt pilates program will last 32 weeks. The intensity of the training will be controlled by the Borg scale of perceived exertion. The training program will have a frequency of two sessions per week, lasting 60 minutes and will be divided into three parts: a) stretching, joint mobility and warm-up; b) main part (according to the objectives of each modality); c) cool-down and final stretching. Both the initial stretching and the final stretching will last five minutes.

exercise program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elderly people over 60 years old,
• sex female our male,
• presenting medical authorization to practice exercises,
• being able to understand verbal instructions for carrying out the tests,
• having accessibility to carry out the training,
• coming from local Health Units and the community,
• presenting independent walking and not having participated in any physical activity for at least three months before starting the research.

You may not qualify if:

• not having a medical certificate indicating that they are fit to perform physical activity,
• presenting medical comorbidities and/or a medical condition that contraindicates participation in the study, severe heart disease, uncontrolled arterial hypertension, myocardial infarction within a period of less than one year or history of physical-cognitive impairment, sequelae of a stroke,
• having a pacemaker,
• having undergone recent surgery,
• prosthetics in the lower limbs or neuropathic pain in the lower limbs.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

MeSH Terms

Conditions

Motor Activity

Interventions

Nordic Walking; Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Central Study Contacts

Andrea Goncalves

CONTACT

+555133085871; andreakg@ufrgs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share