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

• ClinicalTrials.gov Identifier: NCT04868071
• Recruitment Status: Completed
• First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Sponsor: University of Campinas, Brazil
• Information provided by (Responsible Party): Hélio José Coelho Júnior, University of Campinas, Brazil

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Frailty	Behavioral: Physical Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: August 29, 2019
• Actual Study Completion Date: August 29, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: High-Speed Resistance Training; Participants performed exercises 8 times (sets) with 3-5 repetitions at 70%-75% of the maximal strength.	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).; Other Name: Resistance Training
Experimental: Low-Speed Resistance Training; Participants performed exercises 4 times (sets) with 8-10 repetitions at 70%-75% of the maximal strength.	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).; Other Name: Resistance Training
No Intervention: Control Group; No activities

Outcome Measures

Primary Outcome Measures :

1. Frailty Status [ Time Frame: 16 weeks ]
   Frailty status will be assessed using the Fried Frailty Phenotype Scale published in 2001.
2. Physical Performance [ Time Frame: 16 weeks ]
   Physical Performance will be assessed using the sit-to-stand test.
3. Cognitive Function [ Time Frame: 16 weeks ]
   Cognition will be assessed using the Mini Mental State Examination
4. Blood Pressure [ Time Frame: 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Brazil

Cantinho do Idoso Senior Center

Poá, SP, Brazil

Mãe Maria Nursing Home

Poá, SP, Brazil

Sponsors and Collaborators

University of Campinas, Brazil

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Coelho-Júnior HJ, Uchida MC. 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. Front Med (Lausanne). 2021 Jul 26;8:702436. doi: 10.3389/fmed.2021.702436. eCollection 2021.

• Responsible Party: Hélio José Coelho Júnior, Principal Investigator, University of Campinas, Brazil
• ClinicalTrials.gov Identifier: NCT04868071
• Other Study ID Numbers: 20021919.7.0000.5404
• First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Frailty; Pathologic Processes