Effects of a combined exercise programme on physical fitness, heart-rate regulation and continued physical activity in older adults
| ISRCTN | ISRCTN31223043 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31223043 |
| Sponsor | Universidad Autónoma de Nuevo León |
| Funders | Universidad Autónoma de Nuevo León, Investigator initiated and partly investigator funded, DIF Casa Club del Adulto Mayor Los Altos — facilities and logistical support |
- Submission date
- 14/08/2026
- Registration date
- 19/08/2026
- Last edited
- 18/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Ageing is accompanied by changes in muscular strength, endurance, balance, body composition, metabolism and the regulation of heart rate. These changes can affect independence and the ability to carry out everyday activities. Exercise programmes that combine several types of training may help older adults maintain or improve these capacities.
This study examines how a supervised programme combining resistance, aerobic endurance, flexibility, balance and coordination affects physical fitness, functional performance, body composition, metabolic health, heart-rate regulation and continued participation in physical activity. It also examines how these outcomes evolve during a subsequent six-month period when some participants continue supervised training and others stop attending the supervised programme.
Who can participate?
Men and women aged 60 years or older who are functionally autonomous and able to participate safely in physical exercise
What does the study involve?
Sixty older adults participate in the first phase. Participants are recruited from two institutions in Monterrey, Nuevo León. The centre from which they are recruited determines their first-phase group. This first comparison is therefore not randomised.
Participants recruited from Servicios Médicos of the Universidad Autónoma de Nuevo León complete a supervised multicomponent exercise programme three times per week. Participants recruited from DIF Casa Club del Adulto Mayor Los Altos receive no structured exercise programme and continue their usual recreational and social activities, such as board games, crafts and educational talks.
The exercise programme includes resistance, aerobic endurance, flexibility, balance and coordination activities. It is delivered for 24 effective weeks, three times per week, with each session lasting approximately 60 minutes. The difficulty and training load are adjusted according to participants’ abilities and responses.
Assessments are performed before the programme, after three effective months and after six effective months. They include body measurements, body composition and bone health, muscular strength, flexibility, aerobic endurance, mobility, balance, walking and chair-rise performance, blood pressure, glucose, cholesterol, triglycerides, heart-rate variability and stage of physical activity behaviour.
Supervised activities are interrupted for about one month because of an institutional closure. The first six effective months of training therefore take about seven calendar months.
After the first phase, 22 participants from the exercise group enter the second phase and are randomly allocated by a manual paper draw. Eleven continue supervised training and eleven stop attending the supervised programme. Participants who stop the programme are not required to avoid all physical activity, and independently performed activity is not systematically recorded. Both groups are assessed again at months 7, 9 and 12.
What are the possible benefits and risks of participating?
Possible benefits include maintenance or improvement of physical fitness, functional performance, cardiovascular and metabolic health, and confidence in participating in physical activity. Benefits cannot be guaranteed.
Possible risks include temporary fatigue, muscle soreness, sprains, soft-tissue or skeletal injury, dizziness or fainting. Cardiovascular complications may also occur during exercise, although they are uncommon. Participants are screened before participation, monitored during assessments and supervised sessions, and instructed to report symptoms immediately.
Where is the study run from?
The study is conducted through the Faculty of Sports Organization of the Universidad Autónoma de Nuevo León, the Centro de Salud y Bienestar of Servicios Médicos UANL, and DIF Casa Club del Adulto Mayor Los Altos in Nuevo León, Mexico.
When is the study starting and how long is it expected to run for?
August 2018 to September 2019
Who is funding the study?
The study is partly funded by the Programa de Apoyo a la Investigación Científica y Tecnológica of the Universidad Autónoma de Nuevo León, grant SA842-19. The investigators and participating institutions also provide material, facilities and logistical support.
Who is the main contact?
José Raúl Hoyos-Flores, jose.hoyosfl@uanl.edu.mx
Contact information
Principal investigator
Faculty of Sports Organization, Universidad Autónoma de Nuevo León, Niños Héroes, Ciudad Universitaria
San Nicolás de los Garza, Nuevo León
66455
Mexico
 ORCID ID |
0000-0003-0840-2410 |
|---|---|
| Phone | +52 (0)81 1340 4450 |
| silvia.medranomn@uanl.edu.mx |
Public, Scientific
Faculty of Sports Organization, Universidad Autónoma de Nuevo León, Niños Héroes, Ciudad Universitaria
San Nicolás de los Garza, Nuevo León
66455
Mexico
| ORCID ID |
0000-0003-1486-4814 |
|---|---|
| Phone | +52 (0)81 1340 4451 |
| jose.hoyosfl@uanl.edu.mx |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Health services research, Health promotion and maintenance of physical and functional capacity in older adults through multicomponent exercise |
| Scientific title | Effects of supervised multicomponent training versus no structured exercise intervention on physical fitness, cardiac autonomic modulation and physical activity adherence in functionally autonomous older adults: a two-phase controlled study with a quasi-experimental first phase and a randomised maintenance-versus-cessation follow-up |
| Study objectives | The overall objective was to examine the effects of a supervised multicomponent training programme on physical fitness, internal training load, cardiac autonomic modulation and physical activity adherence in functionally autonomous older adults, and to examine the subsequent evolution of these outcomes during supervised maintenance or programme cessation. |
| Ethics approval(s) |
Approved 18/02/2020, Institutional Ethics Committee, Technological Institute of Sonora (5 de Febrero No. 818 Sur, Ciudad Obregón, Sonora, 85000, Mexico; +52 (0)644 410 0900 ext 2139; flares@itson.edu.mx), ref: Dictamen No. 64 |
| Health condition(s) or problem(s) studied | Healthy ageing, including physical fitness, functional performance, cardiometabolic health, cardiac autonomic modulation and physical activity adherence in older adults |
| Intervention | The study comprises two consecutive phases. Recruitment begins on 4 June 2018 through advertisements, leaflets, notices and direct invitations addressed to older adults attending two institutions in Monterrey, Nuevo León, Mexico. Before recruitment, meetings are held with the authorities of each participating centre and the required institutional permissions are obtained. Eligible volunteers within each institution are assigned anonymous identification codes and selected through a simple random-selection procedure until 30 participants have been enrolled at each centre. This random procedure is used only to select participants within each institution and does not determine allocation to the intervention condition. Participants recruited from the Centro de Salud y Bienestar of Servicios Médicos, Universidad Autónoma de Nuevo León, constitute the experimental group. Participants recruited from DIF Casa Club del Adulto Mayor Los Altos constitute the concurrent control group. Therefore, the first phase uses a quasi-experimental, non-randomised, parallel-group design with a non-equivalent control group. All participants receive a verbal and written explanation of the study procedures, potential benefits and risks and provide written informed consent before baseline testing. Baseline assessments are conducted between 13 and 24 August 2018 over two consecutive weeks, with one group assessed each week. Measurements are performed at the participating centres and at the Faculty of Sports Organization of the Universidad Autónoma de Nuevo León. The experimental group begins supervised multicomponent training on 27 August 2018. The initial programme comprises 24 effective weeks, with three 60-minute sessions per week. Each session consists of a 10-minute warm-up, a 40-minute main section and a 10-minute cool-down. The programme combines resistance, aerobic-endurance, flexibility, balance and coordination exercises. Training begins with an adaptation period and progresses through planned changes in exercise difficulty, intensity, volume and density according to participants’ responses and tolerance. Resistance training is performed approximately twice per week for about 20 minutes, targeting the major upper- and lower-body muscle groups. Training comprises approximately 1–3 sets of 8–12 repetitions, with progression from light intensities of approximately 40–50% to moderate intensities of approximately 60–80% of one-repetition maximum. Exercises include bodyweight activities, free movements and elastic resistance. Aerobic-endurance training is performed three times per week for approximately 20 minutes per session, progressing from light or moderate to more vigorous perceived intensity. Activities include dance, marching, light jogging and movement drills, with intensity monitored through perceived exertion. Balance and coordination are trained approximately twice per week for about 10 minutes using static and dynamic tasks, changes of direction, obstacle courses, body-weight transfer and coordinated movements with hoops, balls, ropes, cones and mats. Flexibility is trained approximately three times per week for 10–15 minutes using static and dynamic exercises performed without pain and progressed according to the participants’ abilities. The control group receives no structured exercise intervention. Participants continue their usual recreational and social activities at the institution, including board games, crafts and educational talks. These activities are not prescribed, structured or monitored as physical exercise and are not intended to reproduce any component of the multicomponent training programme. Participants in the experimental and control groups are assessed at baseline (T1), after 3 effective months (T2) and after 6 effective months of intervention (T3). Supervised activities are temporarily interrupted for approximately one month, from mid-December 2018 to mid-January 2019, because of an institutionally determined closure. This interruption is not planned as part of the intervention. Some participants informally report continuing physical activity during this period, but no activity is prescribed, restricted or systematically quantified. Delivery of six effective months of supervised training therefore extends over approximately seven calendar months. Following T3, 22 participants from the experimental group enter the second phase. They are randomly allocated in a 1:1 ratio through a simple manual paper-draw procedure to a maintenance group (n = 11) or a programme cessation group (n = 11). No formal allocation-concealment mechanism is used. The maintenance group continues supervised multicomponent training without interruption for a further six effective months. Training frequency remains at three sessions per week and session duration remains at 60 minutes. Intensity and volume are periodically adjusted within the prescribed ranges to maintain an appropriate relative training stimulus. These adjustments are intended to support the adaptations achieved during the initial intervention. The programme cessation group discontinues the supervised programme delivered by the research team. Participants are not instructed to avoid habitual or self-directed physical activity. Consequently, subsequent activity varies among participants, and its type, frequency, duration and intensity are not systematically recorded. Programme cessation therefore represents withdrawal from the supervised research programme rather than compulsory withdrawal from all physical activity. Both second-phase groups are assessed 1 month after re-randomisation (T4), at month 9 (T5) and at month 12 (T6). The original control group is not assessed during the second phase. Baseline assessment is conducted over 2 weeks, whereas subsequent assessments are generally completed within 3-day windows. During the second phase, both groups are evaluated during the same assessment windows. The study comprises 12 effective months of intervention and follow-up and approximately 13 calendar months because of the institutionally imposed interruption. Outcome-specific analyses may include fewer participants when technically valid measurements are unavailable. Such exclusions do not modify the original enrolment or group-allocation figures of the parent study. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 27/09/2019 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Men and women aged 60 years or older 2. Functionally autonomous older adults able to perform the physical assessments and exercise activities required by the study 3. Apparently healthy or presenting one or more stable, clinically controlled chronic conditions without associated complications that contraindicated exercise 4.Available and willing to attend the study assessments and, when applicable, the supervised multicomponent training programme 5. Able to understand and follow the instructions required for study participation |
| Key exclusion criteria | 1. Medical, musculoskeletal or functional contraindications that prevented safe participation in physical exercise or the study assessments 2. Presence of a pacemaker or another implanted cardiac device 3. Uncontrolled clinical conditions, including uncontrolled blood pressure of 160/100 mmHg or higher 4. Current chest pain, exertional angina, dizziness, fainting, unusual discomfort or other symptoms requiring medical evaluation before exercise participation |
| Date of first enrolment | 13/08/2018 |
| Date of final enrolment | 24/08/2018 |
Locations
Countries of recruitment
- Mexico
Study participating centres
San Nicolás de los Garza, Nuevo León
66455
Mexico
Monterrey, Nuevo León
64460
Mexico
Monterrey, Nuevo León
64370
Mexico
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | De-identified participant-level data supporting the findings of this study may be made available from the corresponding authors upon reasonable written request after publication of the main study results. Requests will be evaluated according to their scientific purpose, participant privacy, ethical and institutional requirements, and compatibility with the original informed consent. Data will be shared only for approved research purposes and, where required, after completion of a data-use agreement. Direct personal identifiers will not be shared. No unrestricted public repository is planned. Requests should be directed to the corresponding authors through jose.hoyosfl@uanl.edu.mx. |
Editorial Notes
17/08/2026: Study's existence confirmed by the Institutional Ethics Committee, Technological Institute of Sonora.
