Boxing Training, Physical-functional Fitness and Cognitive Performance in Older Adults

Study Overview
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Brief Summary
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The aim of the study is to evaluate and to compare the effects of two exercise regime (Boxing Training -BT and Multicomponent Training -MT) on cognitive health status, physical-functional fitness, and risk of falls in community-dwelling elders. This is a quasi-experimental controlled trial using a parallel-group design. Participants will be allocated to 3 groups (i.e. BT, MT or control group [no intervention]). Both exercise programs (BT and MT) will last 24 weeks, twice a week, 45 minutes per session. Only participants in the intervention groups (BT and MT) will be assessed for Senior Fitness test, and body weight at 3 moments (baseline, 12 weeks and 24 weeks). Participants in the control group will participate in the assessments (initial [baseline] and final [24 weeks]). Our hypotheses are: In comparison with the control group, both exercise regimes groups (BT and MT) will positively impact on physical-functional fitness, cognitive health status and risk of falls in community-dwelling elders. The observed effects on physical-functional fitness, cognitive health status, and risk of falls as a result of the BT program will be superior to the effects arisen from the MT exercise regime.

Detailed Description
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Aging is associated with functional and cognitive decline (1, 2), which are causal factors of falls in the elderly. According to available evidence, alleviation of these conditions can be achieved through regular exercise of the multicomponent type (MT) (3). However, in TM programs, muscle power takes a secondary role (5) although it is extremely important to preserve the integrity of the neuromuscular system (6). Studies indicate that combat sports may represent an exercise strategy that combines muscular fitness, cardiorespiratory fitness, agility, and balance (7), in addition to falling within the scope of dual-task programs (i.e., physical and cognitive) because they require memorization of combinations of attacking and defending movements, quick decision-making, and movement by coordinating simultaneous leg and hand movements (8). Seminal work with adapted boxing for elderly parkinsonians has demonstrated positive results in health indicators (9, 10). But the effectiveness of this modality in apparently healthy elderly is still unknown. Therefore, this project aims to compare the effects of boxing training and multi-component training on physical-functional fitness, cognitive performance, and the risk of falls in older people. The study comprises a quantitative quasi-experimental design, will be conducted in the metropolitan area of Porto, Portugal. The study sample will consist of healthy individuals from the community, aged ≥ 60 years, who will be recruited in community programs, municipalities, health centers, and social media platforms through phone calls and informational flyers. Those who accept to participate will be informed about the project objectives and procedures. Participation will be voluntary, and everyone will be required to sign the Free and Informed Consent form. Participants will be allocated into intervention groups: (Boxing training group or Multicomponent training group) or the Control Group (No intervention). The main results will be the physical-functional fitness measured through the Senior Fitness test, Cosmed K5b2, Handgrip strength, ball throw, isokinetic strength, cognitive performance evaluated by neurocognitive and psychological tests, in addition and the risk of falls evaluated by the Biodex® Balance System. Secondary outcomes will be brain activity by means of the electroencephalogram (EEG), bodycomposition, bone mineral density, quality of life and satisfaction with exercise. The research protocol will follow the CONSORT/SPIRIT guidelines.

Official Title
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Impact of Boxing-based Training Program on Physical-functional Fitness, Cognitive Performance, and Risk of Falls in Community-dwelling Older Adults

Conditions
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Healthy People Programs

Intervention / Treatment
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* Other: Boxing training
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants aged ≥60 years; Community-dwelling older adults; Do not present any medical contraindication for physical activity; Exclusion Criteria: Individuals diagnosed with certain disorders or conditions in which exercise is contraindicated such as unstable or ongoing cardiovascular and/or respiratory disorders; Presence of major neurological and Neurocognitive disorders (Portuguese version of the Montreal Cognitive Assessment - MoCA) (12);

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study includes a quasi-experimental design (non-randomized controlled trial), with repeated measures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group 1 (adapted boxing)<br>Experimental boxing - The general structure of adapted boxing will include a 10-minute warm-up consisting of walking at a slow, self-selected speed, and at the same time joint rotation exercises; followed by 25-30 minutes of adapted boxing (consisting of non-contact activities, distributed in coordination and balance/footwork, shadow boxing-choreography (sequence of arm and leg movements that simulate an imaginary fight and punching bag), to end the session there will be a content fixation exercise, relaxation with gentle movements and breathing for 5 -10 minutes. | Other: Boxing training<br>* Training protocol will be held for 24 weeks, twice per week/ 45 min per sessions.<br>* Other names: Combat sports;|
| Active Comparator: Experimental group 2 (multi-component training)<br>Sessions will be divided in 10 minutes warm-up (including slow walk, postural and mobility exercises for general activation, and stretching exercises), specific training (25-30 minutes, including balance/coordination training, strength, and aerobic exercises) and cool down 5 - 10 minutes (breathing and stretching exercises for the main worked joints and muscles) following the main guidelines recommended by the American College of Sports Medicine (4) and the WHO (3). | Other: Exercise<br>* Training protocol will be held for 24 weeks, twice per week/ 45 min per sessions.<br>* Other names: Multicomponent training;|
| No Intervention: Control group<br>Participants from the control group will participate in assessments (initial and final) and will be asked to maintain their usual activities. At the end of the intervention period, the control group will be invited to participate in a physical activity program that takes place at the University. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Physical-Functional Fitness (8-Foot Up and Go Test) 3 months and at 6 months, respectively. | Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT) (23). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The stand up, walk 8-foot distance (2,44 meters), turn the cone marker around and return to the seated position. The time, in seconds, necessary to complete this test will be registered. | Baseline, after 3 months of intervention,6 months | 
| Change from baseline Physical-Functional Fitness (six-minute walk test) 3 months and at 6 months, respectively. | Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT) (23). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The participants walk as fast as possible (without running) around the course as many times as they can within the time limit (6 minutes). | Baseline, after 3 months of intervention,6 months | 
| Change from Baseline Physical-Functional Fitness (strength of the lower and upper body) 3 months and at 6 months, respectively. | Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT) (23). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The chair stand test to assess the strength of the lower body, counting the number of repetitions made in 30s. And the arm curl test to assess the strength on the upper body, using a 3lb (women) and 5lb (men) dumbbell, counting the number of repetitions made in 30s. | Baseline, after 3 months of intervention,6 months | 
| Change from baseline on Handgrip strength at 3 months and at 6 months, respectively. | The handgrip strength will be measured with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA). Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 1 min between them. Three attempts will be made for each hand, using the maximum value of the three registers. | Baseline, after 3 months of intervention,6 months | 
| Change from baseline Upper Body Power at 3 months and at 6 months, respectively. | This will be tested with a 3 kg (Ø 0.60 m) medical ball. Each subject will sit in a chair with the posterior region of the trunk positioned against the back of the chair and hold the ball forward with both hands. Three approved trials will be conducted with one-minute rest intervals between each trial to ensure that fatigue or learning effects do not influence performance. The maximum throwing distance will be determined using a flexible steel tape. Only the best attempt will be used for further analysis (24). | Baseline, 6 months | 
| Change from Baseline peak oxygen uptake (VO2 peak) at 6 months | Modified Bruce Treadmill Test - This sub-maximal test with incremental protocol including seven stages and performed on a treadmill, standard an open-circuit spirometer technique (Cosmed K5b2, Cosmed, Rome, Italy) will be used. | Baseline, 6 months | 
| Change from Baseline Lower-body strength and power at 6 months | The knee extensors and flexors will be evaluated using an isokinetic dynamometer (Biodex System 2, USA) at two different angular velocities: 60°/s and 180°/s (22). | Baseline, 6 months | 
| Change from Baseline cognitive performance (Inhibition/cognitive flexibility) at 6 months | The Stroop Color and Word Test (parameters: words, colors, and words/colors) will be selected to assess response inhibition/cognitive flexibility (14). | Baseline, 6 months | 
| Change from Baseline cognitive performance (Processing speed) at 6 months | Digit Symbol Substitution Test (DSST, subtest of the Wechsler test of adult intelligence WAIS III) (16, 17) will be used as a measure of high-level information processing speed. | Baseline, 6 months | 
| Change from Baseline cognitive performance (Selective recall test) at 6 months | Selective recall test [SRT-List A; parameters: consistent long-term recall, long-term storage, delayed recall, and intrusions] to assess verbal learning and multiple-trial memory (14). | Baseline, 6 months | 
| Change from Baseline cognitive performance (Verbal short-term memory and verbal working memory) at 6 months | The forward digit advancement (DS) test was selected to assess verbal short-term memory and the backward DS to assess verbal working memory (subtest of the Wechsler test of intelligence for adults WAIS III) and total DS score (total DS; calculated by adding forward DS and backward DS) (14, 16). | Baseline, 6 months | 
| Change from Baseline cognitive performance (Memory) at 6 months | Consortium to establish a registry for the Alzheimer's Disease List Test (CERAD), will be used: word list memory; word list recall; and word list recognition. The parameters: total hits and delayed recall hits (13, 14). | Baseline, 6 months | 
| Change from Baseline Psychological testing (Depression) at 6 months | The geriatric depression scale (GDS, short version) (18) will be used for depressive symptoms assessment. The GDS-15 evaluates depressive symptoms during the last week and has a dichotomous response scale (Yes/No). On 10 items (2, 3, 4, 6, 8, 9, 10, 12, 14, 15) the answer Yes is rated 1 point and on the remaining items (1, 5, 7, 11, and 13) the answer No is rated 1 point, in the sense that the score indicates presence of depressive symptomatology. The total score of the items is processed by summing the scores on the 15 items, ranging from 0 to 15 points. The 15-item version of the GDS showed the ability to differentiate depressed from nondepressed subjects (18). | Baseline, 6 months | 
| Change from Baseline Psychological testing (Anxiety and depression) at 6 months | Hospital Anxiety and Depression Scale (HADS) will be used (19). Although the HADS is considered an effective instrument for assessing depressive symptoms in hospital settings, it is a screening measure, and it is of utmost importance to be followed by a psychological assessment. This scale consists of two subscales, one for anxiety and the other for depression. A score between 0 to 7 means absence of depressive or anxious symptoms; a score between 8 to 10 means a possible case of depression or anxiety; and from 11 to 21 as a probable case. | Baseline, 6 months | 
| Change from Baseline Psychological testing (Stress) at 6 months | Perceived Stress Scale (PSS-10) (20) will be used to assess perceived stress. | Baseline, 6 months | 
| Change from baseline on Risk of Falls at 6 months | Risk of falls will be evaluated through the Biodex® Balance System (Biodex, Shirley, NY, EUA), using the Fall Risk Test protocol in which the platform is unstable and allows to obtain the risk index and modified version of the Clinical Test of Sensory Interaction and Balance (CTSIB). | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic Assessments are going to measured at baseline. | Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others), number of medications, diagnosed diseases, falls in the last 12 months. | Baseline | 
| Change from Baseline Brain Activity at 6 months | This will be analyzed using an electromyography (EEG) system. All EEG signals will be acquired with the ActiCHamp®, Brain Products,GmbH. With an international 10-20 system with standard 32-channel electrode layout with reference and ground electrodes. The ground will be located on the forehead and the reference will be the Cz channel of the ActiCHamp® equipment. For each participant, the same equipment will be used in all sessions. | Baseline, 6 months | 
| Change from baseline Quality of Life at 6 months | Quality of life will be tested with the World Health Organization Quality of Life Assessment Tool (WHOQOL-Bref). | Baseline, 6 months | 
| Change from Baseline body mass, fat-free mass, fat mass at 3 months and at 6 months, respectively | Body mass (kg), fat-free mass (kg) and fat mass (kg) will be analyzed with bioimpedance (InBody 120®). | Baseline, 3 months, 6 months | 
| Change from Baseline Appendicular Skeletal Muscle Mass Index at 6 months | Appendicular Skeletal Muscle Mass Index (ASMI), which is the sum of muscle masses of the four limbs described as appendicular skeletal muscle mass adjusted for height (kg/m2), will be analyzed with Dual Energy X-ray Absorptiometry (DXA). | Baseline, 6 months | 
| Change from Baseline Bone Mineral Density at 6 months | They will be analyzed by Dual Energy X-ray Absorptiometry (DXA). | Baseline, 6 months | 
| Exercise satisfaction | Will be tested with the physical activity enjoyment scale (PACES) (26). The Portuguese version of the PACES is a validated and reliable instrument to assess enjoyment in group fitness activities. This scale is composed of eight items (e.g., It is invigorating) preceded by the statement The physical activity I practice... to which participants respond through a Likert-type scale with a minimum score of 1 totally disagree and maximum score of 7 (totally agree). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Public health, Boxing, Elderly