NCT05826314

Brief Summary

The aim of the study is to evaluate and to compare the effects of two exercise regimes (Boxing Training -BT and Multicomponent Training -MT) and 12 weeks of follow-up 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. Participants of all groups will be assessed for Senior Fitness test, and body weight at 4 moments (baseline, 12 weeks and 24 weeks of exercise and a follow-up period lasting 12 weeks). Our hypotheses are:

  1. 1.In comparison with the control group, both exercise groups (BT and MT) will positively improve their physical-functional fitness, cognitive health status and risk of falls with the interventions
  2. 2.The observed effects on physical-functional fitness, cognitive health status, and risk of falls as a result of the exercise programs will be similar.
  3. 3.During the follow-up period, both exercise groups will experiment reductions on physical-functional fitness, cognitive health status, and risk of falls.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

March 20, 2023

Last Update Submit

September 17, 2024

Conditions

Keywords

Public healthBoxingElderlyPhysical Activity

Outcome Measures

Primary Outcomes (18)

  • 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

  • Change from baseline on Handgrip strength to 3 and 6 months of exercise and 3-months of follow-up, 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, 3 months follow-up

  • 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 Physical-Functional Fitness (upper and lower body strength) at 3 and 6 months of exercise and 3-months of follow-up, 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, 3 months follow-up

  • Change from baseline Physical-Functional Fitness (8-Foot Up and Go Test) at 3 and 6 months of exercise and 3-months follow-up, 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, 3 months follow-up.

  • Change from baseline Physical-Functional Fitness (six-minute walk test) at 3 and 6 months of exercise and 3-months follow-up, 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 will be asked to walk the longer distance in 6 min time along a corredor.

    Time Frame: Baseline, after 3 months of intervention, 6 months, 3 months follow-up

  • Change from baseline Physical-Functional Fitness (upper and lower body flexibility) at 3 and 6 months of exercise and 3-months follow-up, 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 sit \& reach test to assess the flexibility of the lower body, measured in cm. And the back scratch test to assess flexibility on the upper body, measured in cm.

    ime Frame: Baseline, after 3 months of intervention, 6 months, 3 months follow-up

Secondary Outcomes (6)

  • Sociodemographic Assessments are going to measured at baseline.

    Baseline

  • Change from baseline Quality of Life at 6 months

    Baseline, 6 months

  • Change from Baseline Appendicular Skeletal Muscle Mass Index at 6 months

    Baseline, 6 months

  • Exercise satisfaction

    6 months

  • Change from Baseline body mass, fat-free mass, fat mass at 3 and 6 months of exercise and 3-months of follow-up, respectively

    Baseline, 3 months, 6 months, 3 months follow-up

  • +1 more secondary outcomes

Other Outcomes (4)

  • Change from baseline Caloric Intake at 6 months

    Baseline, 6 months

  • Exercise intensity

    6 months, during the intervention

  • Applicability of the interventions

    6 months during the intervention

  • +1 more other outcomes

Study Arms (3)

Experimental group 1 (adapted boxing)

EXPERIMENTAL

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

Experimental group 2 (multi-component training)

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Participants from the control group will participate in all assessments moments, 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.

Interventions

Training protocol will be held for 24 weeks, twice per week/ 45 min per sessions.

Also known as: Combat sports
Experimental group 1 (adapted boxing)

Training protocol will be held for 24 weeks, twice per week/ 45 min per sessions.

Also known as: Multicomponent training
Experimental group 2 (multi-component training)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants aged ≥60 years;
  • Community-dwelling older adults;
  • Do not present any medical contraindication for physical activity;

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport, University of Porto

Porto, Porto District, 4200371, Portugal

Location

Related Publications (10)

  • 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.

    PMID: 29450049BACKGROUND
  • 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.

    PMID: 34234373BACKGROUND
  • 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.

    PMID: 33239350BACKGROUND
  • 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.

    PMID: 34534623BACKGROUND
  • 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.

    PMID: 27516536BACKGROUND
  • 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.

    PMID: 29157151BACKGROUND
  • 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.

    PMID: 31282426BACKGROUND
  • 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.

    PMID: 34806626BACKGROUND
  • 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.

    PMID: 21088118BACKGROUND
  • 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.

    PMID: 23851406BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lucimere Bohn, PhD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR
  • Kessketlen Miranda, PhD student

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study includes a quasi-experimental design (non-randomized controlled trial), with repeated measures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 24, 2023

Study Start

October 17, 2023

Primary Completion

April 1, 2025

Study Completion

August 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Participant data will not be shared. We will only disseminate the results of the study through scientific papers and presentations at scientific conferences

Locations