An interventional study of IPC + Exercise protocol and Sham IPC + Exercise protocol in Older People, sponsored by University of Valencia. Completed at 2 sites in Spain. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
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:
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.
University of Valencia is the lead sponsor of 355 studies on the registry; 74 are open to participants now.
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Exclusion Criteria:
Patients in this group (n=16) will undergo ischaemic preconditioning (IPC) plus an endurance training protocol.
Other: IPC + Exercise protocol
Patients in this group (n=16) will undergo sham ischaemic preconditioning (IPC) plus an endurance training protocol.
Other: Sham IPC + 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.
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.
Cardiorespiratory fitness
"6 minutes walking test" (6MWT)
Time frame: 8 minutes
Heart rate variability during walking
Heart rate monitor RS800CX (Polar Electro Oy Kempele, Finland).
Time frame: 40 minutes
Lower limb strength: for the assessment of isometric strength
A load cell (CTCS; Mutronic) will be used to measure the strength of the intrinsic and extrinsic muscles of the hip, knee and ankle
Time frame: 10 minutes
Muscle mass (sacopenia)
Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).
Time frame: 3 minutes
General physical condition
Short Physical Performance Battery
Time frame: 5 minutes
Fatigue
Borg scale 20
Time frame: 1 minute
Fall risk, agility and dynamic balance
Fall skip
Time frame: 3 minutes
Independence in basic activities of daily living (BADL) and instrumental activities of daily living (IADL)
Barthel Index and Lawton and Brody scale, respectively
Time frame: 5 minutes
Health-related Quality of Life
EQ-5D-5L
Time frame: 2 minutes
Plan to share: No
Ran from Nov 2021 to primary completion in Dec 2023, 25 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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