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

Healthy People Programs Clinical Trial

— Boxe4Ageing  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826314
• Other study ID #: 262022
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: October 15, 2025

Study information

• Verified date: November 2023
• Source: Universidade do Porto
• Contact: Lucimere Bohn, PhD
• Phone: +351 917 028 600
• Email: lucimerebohn[@]fade.up.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. 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.

2. 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Healthy People Programs

Intervention

Other:
• Boxing training
Training protocol will be held for 24 weeks, twice per week/ 45 min per sessions.
• Exercise
Training protocol will be held for 24 weeks, twice per week/ 45 min per sessions.

Locations

Country	Name	City	State
Portugal	Faculty of Sport, University of Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (10)

Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955. — View Citation

Combs SA, Diehl MD, Staples WH, Conn L, Davis K, Lewis N, Schaneman K. Boxing training for patients with Parkinson disease: a case series. Phys Ther. 2011 Jan;91(1):132-42. doi: 10.2522/ptj.20100142. Epub 2010 Nov 18. — View Citation

Domingos J, Radder D, Riggare S, Godinho C, Dean J, Graziano M, de Vries NM, Ferreira J, Bloem BR. Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. J Parkinsons Dis. 2019;9(3):615-623. doi: 10.3233/JPD-191616. — View Citation

Hill NL, Bhargava S, Brown MJ, Kim H, Bhang I, Mullin K, Phillips K, Mogle J. Cognitive complaints in age-related chronic conditions: A systematic review. PLoS One. 2021 Jul 7;16(7):e0253795. doi: 10.1371/journal.pone.0253795. eCollection 2021. — View Citation

Hunter SK, Pereira HM, Keenan KG. The aging neuromuscular system and motor performance. J Appl Physiol (1985). 2016 Oct 1;121(4):982-995. doi: 10.1152/japplphysiol.00475.2016. Epub 2016 Aug 11. — View Citation

Origua Rios S, Marks J, Estevan I, Barnett LM. Health benefits of hard martial arts in adults: a systematic review. J Sports Sci. 2018 Jul;36(14):1614-1622. doi: 10.1080/02640414.2017.1406297. Epub 2017 Nov 21. — View Citation

Santos-Eggimann B, Sirven N. Screening for frailty: older populations and older individuals. Public Health Rev. 2016 Aug 22;37:7. doi: 10.1186/s40985-016-0021-8. eCollection 2016. — View Citation

Shearin S, Braitsch M, Querry R. The effect of a multi-modal boxing exercise program on cognitive locomotor tasks and gait in persons with Parkinson disease. NeuroRehabilitation. 2021;49(4):619-627. doi: 10.3233/NRE-210218. — View Citation

Streit IA, Pinto SS, Silva ADS, Bezerra ES. Body weight multicomponent program improves power and functional capacity responses in older adults: A quasi-experimental study. Exp Gerontol. 2021 Nov;155:111553. doi: 10.1016/j.exger.2021.111553. Epub 2021 Sep 14. — View Citation

Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Daily Physical Activity levels at 6 months	Daily physical activity will be collected with the activity monitors GT3X+ (ActiGraph). Devices are going to be placed on participant´s waist, to measure the activity intensity (counts per minute) during one week. Is addition, physical activity will be also self reportedwith the IPAQ short version (IPAQ-SV).	Baseline, 6 months
Other	Change from baseline Caloric Intake at 6 months	Caloric intake will be evaluated by a 4-day food record. Macronutrients (i.e., carbohydrate, protein, and fat) will be analyzed as a percentage of total calories consumed.	Baseline, 6 months
Other	Exercise intensity	Borg Rating of Perceived Exertion	6 months, during the intervention
Other	Applicability of the interventions	Adverse events, discomfort or chest pain during training will be measured with the Borg Category ratio scale (CR-10).	6 months during the intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline Bone Mineral Density at 6 months	They will be analyzed by Dual Energy X-ray Absorptiometry (DXA).	Baseline, 6 months
Secondary	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