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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]

Secondary outcome measures (4)

• 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).]
• 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).]
• 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).]
• 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06638697 · 36044620.5.0000.5336

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗