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NCT Number: NCT06638697

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

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.

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Key information

Conditions

Aged Aged Subject Behavior Motor Activity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Primary outcomes

  1. Lower Limb Strength

    Time frame: 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).

    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).

  2. Upper limb strength

    Time frame: 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).

    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.

  3. Upper limb flexibility

    Time frame: 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).

    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).

  4. Lower limb flexibility

    Time frame: 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).

    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).

  5. Aerobic endurance

    Time frame: 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).

    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

  6. Static balance

    Time frame: 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).

    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.

  7. Dynamic balance

    Time frame: 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).

    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).

  8. Walking speed

    Time frame: 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).

    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).

Secondary outcomes

  1. Concern about falls

    Time frame: 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).

    Falls Efficacy Scale International (FES-I) - The FES-I is a scale for assessing self-efficacy related to falls. The instrument presents questions about concern about the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 points (no concern) to 64 points (extreme concern).

  2. Pain index

    Time frame: 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).

    McGill Pain Questionnaire - The instrument is used to measure the quality and intensity of pain, the patient chooses between 15 words and the pain is classified in its sensory and affective dimensions, along with an analog scale that evaluates the general intensity of pain in the last few days and a 6-item scale with a global description of intensity.

  3. Depressive symptoms

    Time frame: 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).

    Geriatric Depressive Symptoms (GDS-15) - The GDS-15 is a widely used and validated scale as a diagnostic instrument for depression in the elderly. It is a self-assessed scale for assessing depressive symptoms, consisting of 15 questions, in which a score of five or more points is indicative of a probable depressive episode.

  4. Cognition

    Time frame: 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).

    General cognition - evaluated with the Montreal Cognitive Assessment (MoCA). It covers various cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation). Scores on the MoCA can range from 0 to 30, with higher scores indicating better cognitive function. Participants will be classified in cognitively unimpaired (CU), mild cognitive impairment (MCI), and dementia according to the total MoCA score.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Goncalves

CONTACT

[email protected]

+555133085871

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

CREM - Reference Center for Aging and Movement: Clinical and Functional Outcomes in a Controlled Clinical Trial with Older Adults

Acronym: CREM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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