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Completed

NCT Number: NCT04868071

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

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantinho do Idoso Senior Center, Poá, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

Behavioral

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 names: Resistance Training

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study 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

Acronym: RTF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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