COMMUNITY-BASED POWER TRAINING IN FALLER AND NON-FALLER OLDER ADULTS: A FEASIBILITY AND FALL RISK STUDY.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Maia

About this trial

Aging leads to substantial alterations in the nervous and skeletal muscle systems that ultimately lead to a reduction in "neural drive" and motor performance. While maximal strength starts declining as early as 50 years of age, aging brings even greater reductions in rate of force development and muscle power, that has been shown to be a stronger predictor of functional independence and balance impairments.

Falls are a major health concern as one third of adults over 65 years loses balance and falls every year, and based on a published report, the estimated health care costs associated with falls in the European Union is €25 billion.

The ability to recover balance declines with aging, where older individuals often recover balance with a greater number of balance recovery steps and non-optimal stepping strategies. In addition, older adults have more difficulty recovering balance in the medio-lateral direction. The hip abductors are fundamental in controlling the motion of the body centre of mass in this direction during weight transfers of standing, stepping, and walking.

Furthermore, these muscles appear to be more susceptible to age-related composition and performance declines than other muscles of the lower limbs, especially in individuals at a higher risk for falls.

Unfortunately, common balance interventions, such as, functional balance training, Tai-Chi, or dance, have a very limited capacity to reduce the risk of falls in older adults. Interestingly, resistance training is relatively better than the mentioned interventions at reducing this problem. This may come about through mitigating the agerelated neuromuscular performance deficits. However, traditional resistance training lacks the emphasis in high velocity movements required for adequate fall prevention protective stepping strategies. Muscle power training is a safe and effective alternative to traditional resistance training. By emphasizing in maximum speed of execution, its results are often better than with traditional resistance training, especially in functional outcomes, with the potential to enhance balance recovery. However, there is little and inconsistent evidence on the optimal exercise parameters (such as velocity) for prevention of falls.

Community-based multi-component exercise programs are often used to promote health and functional benefits in the older adult population. These programs not only have a positive impact in a larger number of communitydwelling individuals, but can also lead to significant improvements. Nonetheless, these programs limited in reducing the risk for falls. Considering the robust effects of muscle power training in the older population, it is conceivable that a multi-component community-based exercise intervention, that focuses on developing muscle power and reduce fall risk, can improve the older individuals' ability to recover balance and consequently, bring greater benefits to the older adult community. However, there is no information on the feasibility of conducting an exercise program to develop muscle power and reduce fall risk in a community-based setting. Furthermore, it is generally unknown if such an exercise intervention can improve function, balance, and reduce the occurrence of falls in older adults especially, among those that have fallen in the past- which are the most relevant target population for both clinical studies and practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 65-85 years;

Fall history over the 12 months prior to enrollment (fallers group).

Disqualifiers

Any existing medical conditions or injuries which would affect the ability or safety to perform exercise;

Taking medication affecting balance (such as sedatives, anti-depressives);

Regular (more than 1d/week) participation in resistance training with loading greater than bodyweight during the last year;

BMI greater than 32 kg/m2.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Multi-component exercise program focused on muscle power

    Behavioral

    The intervention will be applied for 12 weeks, with a frequency of 3 times per week. Each session will have 45 minutes, and the participants will be instructed to perform a warm-up on a treadmill or other cardiofitness equipment, power training, and balance exercise. Participants in the power training groups (30 non-fallers and 30 fallers) will perform knee extension, hip extension and hip abduction exercises, in a regimen of 3 sets of 10 repetitions at 50% of the participant's 1 repetition maximum (1RM), performing each repetition as fast as possible on variable resistance machines. The 1RM estimation will be determined using a 10RM protocol and applying Brzycki's equation. The 1RM assessment will be conducted during the first training session and will be reassessed every 3 weeks to progressively adjust resistance training loads. The progression on the balance exercise (stepping and manipulation of the centre of mass over the base of support) will be equally performed every 3 weeks.

  • Multi-component exercise program focused on traditional resistance training

    Behavioral

    The intervention will be applied for 12 weeks, 3 times per week. Each session will have 45 minutes, and the participants will be instructed to perform a warm-up on a cardiofitness equipment, resistance exercise, and balance exercise. Participants in the traditional resistance training groups (30 non-fallers and 30 fallers) will perform knee extension, hip extension and hip abduction exercises, in a regimen of 3 sets of 10 repetitions at 60-75% of the participant's 1 repetition maximum (1RM), at a cadence of 2s concentric and 2s eccentric on variable resistance machines. The 1RM estimation will be determined using a 10RM protocol and applying Brzycki's equation. The 1RM assessment will be conducted during the first training session and will be reassessed every 3 weeks to progressively adjust resistance training loads. The progression on the balance exercise (stepping and manipulation of the centre of mass over the base of support) will be equally performed every 3 weeks.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Traditional Resistance Training in Older FallersExperimental treatment 1 intervention
Group B: Traditional Resistance Training in Older Non-FallersExperimental treatment 1 intervention
Group C: Power Training in Older FallersExperimental treatment 1 intervention
Group D: Power Training in Older Non-FallersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neuromuscular Assessments

Handgrip strength was assessed through sustained isometric maximal voluntary contractions (IMVC) using a digital handgrip dynamometer (Gripwisetech, PT). Participants were seated with the shoulder adducted, elbow flexed at 90°, forearm in neutral position and wrist in slight extension. Three maximal isometric contractions of 15 seconds were performed with the dominant hand, with 2 minutes of rest between trials. Maximal force was defined as the highest peak force achieved during the contraction. Rate of force development (RFD) was calculated as the slope of the force-time curve during the initial phase of contraction (0-200 ms). The best trial was used for analysis.

Time frame
12 weeks
2

Neuromuscular Assessments

Maximal isometric strength of the knee extensors, hip extensors, and hip abductors was assessed using isometric maximal voluntary contractions (IMVC) with a computer-controlled dynamometer (DESMOTEC, IT). All contractions were performed at the joint neutral position (0°) defined for each test. Participants performed the tests in a seated position for knee extension and in a standing position for hip extension and hip abduction, using standardized testing positions. For each muscle group, three maximal isometric contractions of 15 seconds were performed, with 2 minutes of rest between trials. Maximal force was defined as the highest peak torque achieved during the contraction. Rate of force development (RFD) was calculated from the slope of the torque-time curve during the initial phase of the contraction (0-200 ms). The best trial was used for analysis. Data were sampled at 100 Hz.

Time frame
12 weeks
3

Functional Mobility and Balance

Time to complete four meters at the preferred gait speed (4MWT).

Time frame
12 weeks
4

Functional Mobility and Balance

Time to complete the Four Square Step Test (FSST).

Time frame
12 weeks

Secondary outcomes

1

Feasibility (Recruitment Rate)

Proportion of eligible participants who were enrolled in the study, expressed as a percentage (%). The analysis of feasibility and safety of the interventions will include recruitment rate, adherence to the intervention, and adverse events.

Time frame
12 weeks
2

Feasibility (Intervention Adherence)

Percentage of prescribed intervention sessions attended by participants during the intervention period (%). The analysis of feasibility and safety of the interventions will include recruitment rate, adherence to the intervention, and adverse events.

Time frame
12 weeks
3

Safety (Adverse Events)

Number and type of adverse events collected monthly through a structured questionnaire during both the control period and the intervention period. The analysis of feasibility and safety of the interventions will include recruitment rate, adherence to the intervention, and adverse events.

Time frame
12 weeks
4

Prospective falls incidence

Prospective falls incidence will be recorded as the number of unintentional falls occurring during the 6 months between Post-Ret.

Time frame
6 months

Other outcomes

Sponsors and contacts

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University of Maia

Lead sponsor

Research Center in Sports Sciences, Health Sciences and Human Development

Collaborator