Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status

Frailty Clinical Trial

— RTF  

Official title:

Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status, Physical Performance, Cognitive Function, and Blood Pressure in Prefrail and Frail Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868071
• Other study ID #: 20021919.7.0000.5404
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: April 2021
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study refers to a three-arm randomized controlled trial that investigated the effects of two types of RT on frailty status, physical performance, cognitive function, and blood pressure of prefrail and frail older adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

Inclusion Criteria:

• a) aged 60 years or over; b) were prefrail or frail according to Fried's criteria; c) performed the sit-to-stand test alone, with a mobility aid, or researcher's help; d) possessed sufficient physical and cognitive abilities to perform exercise sessions; and e) had a physician authorization to participate.

Exclusion Criteria:

• Exclusion criteria included having participated in a structured physical exercise training program in the past six months, prescription of hormone replacement therapy and/or psychotropic drugs, and any unstable cardiovascular event (e.g., myocardial infarction) or complication in the past 6 months.

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Physical Exercise
Exercise interventions were carried out over a total of 16 weeks in the mornings (08:00 am-12:00 am) under the supervision of at least two fitness instructors. Participants performed four exercises for lower limbs (Figure 9): 1st) squat on the chair, 2nd) seated unilateral hip flexion, 3rd) seated unilateral knee extension, and 4th) bilateral calf raise with 12-15 submaximal repetitions avoiding fatigue (i.e., inability to complete a repetition in a full range of motion). The number of sets was increased linearly during the first month, such that one set was performed in the 1st week, two sets in the 2nd week, 3 sets in the 3rd week, and 4 sets in the 4th week. Subsequently, participants performed the main exercise period. After a brief warm-up, participants performed the same exercises that were performed during the familiarization period using an adjustable weight vest and ankle weights (DOMYOS®, Shangai, China).

Locations

Country	Name	City	State
Brazil	Cantinho do Idoso Senior Center	Poá	SP
Brazil	Mãe Maria Nursing Home	Poá	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty Status	Frailty status will be assessed using the Fried Frailty Phenotype Scale published in 2001.	16 weeks
Primary	Physical Performance	Physical Performance will be assessed using the sit-to-stand test.	16 weeks
Primary	Cognitive Function	Cognition will be assessed using the Mini Mental State Examination	16 weeks
Primary	Blood Pressure		16 weeks