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Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People

Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People: a Randomised Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05144815
Enrollment
31
Registered
2021-12-03
Start date
2021-11-12
Completion date
2023-12-30
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older People

Brief summary

In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018). In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, & Harridge, 2019). A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, & Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, & Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking. Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.

Detailed description

In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018). In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, & Harridge, 2019). Resistance or endurance training can improve sarcopenia, reduce intramuscular fat accumulation, improve muscle function, among others. Aerobic exercise has been shown to be effective in maintaining muscle mass and strength in older adults is walking (Kubo et al., 2008). In fact, walking can also improve VO2max in older adults when intensities are above ∼40% VO2max (Nemoto, Gen-no, Masuki, Okazaki, & Nose, 2007). In addition, it has been linked to the prevention of cognitive decline (Maki et al., 2012) and improvements in quality of life (Awick et al., 2015) in older people. A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, & Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, & Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking. Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions. Therefore, this study is a randomized clinical trial in which three groups of twenty people in each group will participate, with different interventions: * Experimental group 1: Exercise protocol + IPC. * Experimental group 2: Exercise protocol + sham IPC. * Control group. Participants will be evaluated in four moments, at baseline, immediately after the first session, postintervention (after 6-week intervention) and 4-week follow-up. Data analysis will be performed with SPSS statistic program (v26). Normality and homoscedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. For comparation between groups Bonferroni will be used. If any confusion factor that not meet requirements to be analysed like a covariable exist, ANCOVA will be used. When p\<0.0.5 statistical significant differences will be assumed.

Interventions

OTHERIPC + Exercise protocol

The intervention consists of two parts: IPC and endurance training protocol. IPC: participants will be placed in a supine position and a pneumatic compression cuff (Riester Komprimeter, Jungingen Germany) (96 centimetres long x 13 centimetres wide) will be placed on the proximal part of each lower extremity. Occlusion will then be performed by inflating the cuff to 220 mmHg for 5 minutes, followed by reperfusion to 0 mmHg for 5 minutes. Each session will consist of 3 sets of 5 minutes of ischaemia followed by 5 minutes of reperfusion. Endurance training protocol: walking 20 min at moderate intensity (i.e. 64- 76 % HRmax, 12-13 Borg Scale) in a circuit designed in an open field, 3 times a week, for 6 weeks.

OTHERSham IPC + Exercise protocol

The intervention consists of two parts: sham IPC and endurance training protocol. Sham IPC: the pressure cuff will be inflated by only 10 mmHg, so that it will act as a placebo. Endurance training protocol: walking 20 min at moderate intensity (i.e. 64- 76 % HRmax, 12-13 Borg Scale) in a circuit designed in an open field, 3 times a week, for 6 weeks.

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Age between 65 -90 years * Physically inactive (\< 150 minutes of physical activity per week). * Signed informed consent form

Exclusion criteria

* Institutionalised patients. * History of stroke in the last 6 months or hospital admission for any reason in the last 3 months. * Uncontrolled hypertension. * Medication with anticoagulants. * Oncological patient with active treatment: chemotherapy or radiotherapy. * Neurological or cardiovascular musculoskeletal pathology that contraindicates physical activity. * Cognitive impairment (score below 25 on the Mini-mental Test); or severe disability (score below 15 points on the Barthel scale). * Completion of less than 80% of training sessions.

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory fitness8 minutes6 minutes walking test (6MWT)
Heart rate variability during walking40 minutesHeart rate monitor RS800CX (Polar Electro Oy Kempele, Finland).

Secondary

MeasureTime frameDescription
General physical condition5 minutesShort Physical Performance Battery
Fatigue1 minuteBorg scale 20
Lower limb strength: for the assessment of isometric strength10 minutesA load cell (CTCS; Mutronic) will be used to measure the strength of the intrinsic and extrinsic muscles of the hip, knee and ankle
Independence in basic activities of daily living (BADL) and instrumental activities of daily living (IADL)5 minutesBarthel Index and Lawton and Brody scale, respectively
Health-related Quality of Life2 minutesEQ-5D-5L
Fall risk, agility and dynamic balance3 minutesFall skip
Muscle mass (sacopenia)3 minutesBioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026