none
Conditions
Interventions
Intervention period: 3 months
Types of intervention:
1) Active treatment and exercise therapy group: Ambroxol hydrochloride 45 mg administered orally once daily. Exercise therapy (resistance training
Sukonavi will be used solely for data collection purposes.
3) Placebo and exercise therapy group: Placebo tablets administered orally once daily. Exercise therapy (resistance training three times a we
Sukonavi will be used solely for data collection purposes.
Sponsors
Nagao Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 50 or older but under 80 at the time of consent 2) Capable of physical activity 3) Hasegawa Dementia Scale score: 21 or higher 4) 6-minute walk test: 200 m or longer 5) Person who can prepare a smartphone and an email address and consent to downloading the necessary program onto the smartphone 6) Person who are determined by the principal investigator (or sub-investigator) to be able to appropriately evaluate the efficacy and safety of this study based on the inclusion criteria and exclusion criteria
Exclusion criteria
Exclusion criteria: 1) Unable of exercise therapy or exercise tolerance testing 2) Any comorbidities that would interfere with exercise therapy 3) Awaiting heart transplantation or other major surgery scheduled within one year of consent 4) Person who regularly engage in vigorous exercise 5) Person who are determined to be unsuitable for this trial by the principal investigator (or sub-investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in walking distance in the 6-minute walk test approximately 3 months after the start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in grip strength - Change in cytokine array of T cells - Changes in inflammatory cytokines, IL-6 orTNF-alpha - Change in Hasegawa Dementia Scale - Change in pulse rate by Sukonavi - Rate of serious adverse events | — |
Contacts
Public ContactMasashi Nagao
Juntendo University
Outcome results
None listed