Clinical trial NCT03892278: Effects of Water-based Aerobic and Combined Training in Elderly Woman
Official title: Effects of 16 Weeks of Different Water-based Training Programs on Neuromuscular, Cardiorespiratory, Functional Capacity, Quality of Life and Cognitive Function Variables in Elderly Woman: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly Women
Keywords: combined training
aerobic training
aquatic exercises
aging
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 52
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: Investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.

Materials and methods: Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): water-based aerobic training (WBA) and control group (CG). After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC). The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session. The WBA training will be performed in the percentages of heart rate corresponding to the anaerobic threshold and the resistance training sets will be performed at maximal effort. Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17). The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).

Detailed description: Aging process has its own characteristics, among which the direct association with reductions in muscle mass, muscle strength and cardiorespiratory fitness are highlighted. These reductions cause impairment in functional capacity, affecting the efficiency of elderly individuals to perform daily living tasks. However regular exercise practice can be efficient to mitigate factors associated with aging.

A modality that has been well suited for individuals over 60 years is the water-based exercises training, precisely due to the beneficial conditions of the aquatic environment, such as the lower impact on the lower limbs joints in comparison to the impact observed during exercises performed on land

The aim of the study is to investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.

Volunteer old women age range: 60-75 years old, will participate to this study, and will randomly divided into three groups: water-based aerobic training group (WBA), water-based aerobic and combined training group (WBAC) and control group (CG).

Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): WBA and CG. After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC).

The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session.

Participants who will be randomized for WBA group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-2), participants will carry out three 3-minute series of each exercise whose intensity corresponds 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4), participants will perform three 3-minute series of each exercise corresponding to 85-90% of HRat. In the third mesocycle, participants will perform three 3-minute series of each exercise at intensity corresponding to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, participants will perform three 3-minute series of each exercise at intensity corresponding to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) comprises three 3-minute series of each exercise whose intensity corresponds to the 100-105% of HRat for 2 minutes and \<85% of HRat for 1 minute. The last mesocycle (weeks 14-16) comprises three 3-minute series of each exercise whose intensity corresponds to the 105-110% of HRat for 2 minutes and \<85% of HRat for 1 minute.

Resistance training will be divide into two blocks of exercises, and each block will be compose of one exercise for the upper and one for the lower limbs. Block 1 will consist of shoulder flexion and extension (bilateral) and hip flexion and extension (unilateral) exercises. Block 2 will consist of elbow flexion and extension (bilateral) and knee flexion and extension, starting from 90° of hip flexion (unilateral), exercises. In the first mesocycle (weeks 9-10) participants will perform 2 sets of 30 s for each block with the following sequence: 30 s of exercise for the lower limb (right leg), 5 s for switching, 30 s of exercise for the lower limb (left leg), 5 s for switching and 30 s of exercise for the upper limbs. The blocks sequences and intervals will be as follows: block 1 (4 min 20s), interval between blocks (1 min) and block 2 (4 min 20 s). In the second mesocycle (weeks 11-13) participants will perform 3 sets of 20 s for each block.The blocks sequences and intervals will be as follows: 3 times block 1 (6 min 10 s), interval between blocks (1 min) and block 2 (6 min 10 s). In the third mesocycle (weeks 14-16) the participants will perform 4 sets of 15 s for each block. The blocks sequences and intervals will be as follows: 4 times block 1 (8 min 10 s), interval between blocks (1 min) and 4 times block 2 (8 min 10 s).

Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17).

The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).

Eligibility criteria: Inclusion Criteria:

* Volunteer elderly women, aged between 60-75 years old who were not participating on any regular training program in the last four months

Exclusion Criteria:

* Cardiovascular disease (except hypertension controlled by medication);
* Physical impairments for exercise diagnosed through anamnesis;

Primary outcomes:
measure: Maximal dynamic strength change after eight and sixteen weeks (Kg)
timeFrame: Baseline, 8 week and 16 week
measure: Maximal voluntary isometric contraction of knee extensors change after eight and sixteen weeks
timeFrame: Baseline, 8 week and 16 week
measure: Maximum muscular activity of vastus lateralis and rectus femoris change after eight and sixteen weeks
timeFrame: Baseline, 8 week and 16 week
measure: Muscle thickness and echo intensity of knee extensors change after eight and sixteen weeks
timeFrame: Baseline, 8 week and 16 week
Secondary outcomes:
measure: Dynamic muscular resistance change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Cardiorespiratory Fitness evaluation change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Cardiorespiratory Fitness evaluation change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Cardiorespiratory Fitness evaluation change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Heart rate change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Blood pressure change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Functional capacity change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Functional capacity change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Functional capacity change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Functional capacity change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Functional capacity change after sixteen weeks
timeFrame: Baseline and 16 week
measure: Quality of Life change after sixteen weeks (Score)
timeFrame: Baseline and 16 week
measure: Quality of Life change after sixteen weeks (Score)
timeFrame: Baseline and 16 week
measure: Cognitive function change after sixteen weeks (Score)
timeFrame: Baseline and 16 week
measure: Occurrence of low back pain change after sixteen weeks (%)
timeFrame: Baseline and 16 week
measure: Intensity of low back pain change after sixteen weeks (Scale)
timeFrame: Baseline and 16 week
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Universidade Federal de Pelotas
state: Rio Grande Do Sul
Study officials:
affiliation: UFPel
name: Stephanie Pinto, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hafele MS, Alberton CL, Hafele V, Schaun GZ, Nunes GN, Calonego C, Castro TF, Andrade LS, Pinto SS. Water-Based Training Programs Improve Functional Capacity, Cognitive and Hemodynamic Outcomes? The ACTIVE Randomized Clinical Trial. Res Q Exerc Sport. 2023 Mar;94(1):24-34. doi: 10.1080/02701367.2021.1935433. Epub 2022 Mar 16.
citation: Hafele MS, Alberton CL, Schaun GZ, Hafele V, Nunes GN, Andrade LS, Pinto SS. Quality of life responses after combined and aerobic water-based training programs in older women: a randomized clinical trial (ACTIVE Study). Aging Clin Exp Res. 2022 May;34(5):1123-1131. doi: 10.1007/s40520-021-02040-5. Epub 2022 Jan 13.