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

October 11, 2024 updated by: Andrea Kruger Goncalves, Federal University of Rio Grande do Sul

CREM - Reference Center for Aging and Movement: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: exercise program
Participants will receive intervention of different physical training for 32 weeks and will be periodized in an equivalent way.
Other: Free walking
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.
Other: Nordic walking
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.
Other: Dance
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.
Other: Physical exercise for cognition
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.
Other: Balance
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.
Other: Aquatic physiotherapy
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.
Other: Multicomponent gymnastics
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.
Other: Water aerobics
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.
Other: Hydroposture
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.
Other: deep water walking
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.
Other: Weight training
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.
Other: Mat pilates
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
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.
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
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).
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
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).
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
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
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
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.
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
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).
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
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
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.
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
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.
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
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 36044620.5.0000.5336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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