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临床试验/NCT07437521
NCT07437521已完成不适用

The Effect of Periodic Assessment and Verbal Feedback on Physical Function, Adherence and Self-perceived Competence in Healthy Adults Aged ≥65: a Pilot Randomized Controlled Trial

University of West Attica1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年10月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Short Physical Performance Battery (SPPB)

研究概览

简要总结

The goal of this pilot Randomized Controlled Trial (RCT) was to investigate whether the provision of periodic assessment and verbal feedback during an exercise program has an effect on adherence, physical function and self-perceived competence in healthy community-dwelling older adults, aged ≥65 years.

An exercise program with periodic assessment and individualized verbal feedback was compared to the same exercise program delivered without individualized assessment and feedback to determine differences in adherence, functional performance, and self-perceived ability in community-dwelling older adults.

Participants:

  • participated in a structured exercise program for 12 weeks (2times/week)
  • underwent periodic assessments and received verbal feedback (intervention group only).

详细描述

This study is a pilot RCT that included healthy adults aged 65 years and older, with active registration in the Senior Citizens' Centers (KAPI) of the Municipality of Nikaia-Agios Ioannis Rentis, Athens, Greece. Ethical approval for the study was obtained from the Ethics Committee of the University of West Attica (Protocol No. 107620/24-10-2025) before study initiation.

Prior to participation, all eligible candidates received written information about the study and their voluntary participation, and provided written informed consent in accordance with the Declaration of Helsinki. Candidates who confirmed their willingness to participate were subsequently screened for eligibility based on the inclusion and exclusion criteria and they were allocated into two groups using a randomized procedure. Group allocation was known to the participants; however, the physiotherapist delivering the exercise program was blind to group assignment (intervention or control).

All participants followed the same structured and supervised exercise program, delivered by a municipal physiotherapist, with a duration of 12 weeks and a frequency of two sessions per week and a 48-hour interval between sessions. Each session lasted approximately 50 minutes and included warm-up, main exercise, and cool-down components. Exercise intensity was moderate, individually adapted based on perceived exertion, and progressively increased over time.

At baseline assessment, all participants completed the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) to assess exercise motivation, the Activities-specific Balance Confidence (ABC) Scale to evaluate self-reported balance confidence during activities of daily living, and the Self-Efficacy for Exercise (SEE) Scale. Physical performance and functional mobility were assessed using the Short Physical Performance Battery (SPPB) and the Timed Up and Go (TUG) test. Exercise adherence was monitored throughout the intervention period by means of attendance records completed at each session.

Participants allocated to the intervention group underwent three additional assessments at weeks 3, 6, and 9 using the TUG test and the ABC Scale, conducted under conditions consistent with baseline assessments by the same evaluator. Following each assessment, participants in the intervention group received brief, individualized, and encouraging verbal feedback regarding their performance and progress. The control group did not receive additional periodic assessments or feedback.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults of any gender, aged 65 years and older
  • Actively registered at the Senior Citizens' Clubs (KAPI) of the Municipality of Nikaia - Agios Ioannis Rentis, Athens, Greece
  • Required to live independently in their own homes
  • Able to stand, move, and perform activities of daily living without assistance

排除标准

  • Explicit recommendation from the participant's physician not to participate in an exercise program
  • Serious underlying medical conditions, neurological disorders, or any contraindications to physical exercise (e.g., severe heart disease or uncontrolled hypertension)
  • Significant limitations in mobility or functional capacity
  • Inability to complete the Short Physical Performance Battery tests
  • Hypotension or orthostatic hypotension
  • Psychiatric disorders
  • Cognitive impairment (Mini-Mental State Examination score <24/30)
  • Visual or hearing impairments limiting the ability to participate in exercise
  • Use of medications restricting the ability to engage in physical activity

研究组 & 干预措施

Assessment & verbal feedback

Experimental

Participants received periodic assessments and individualized verbal feedback.

干预措施: Periodic assessment and individualized verbal feedback (Behavioral)

Control

No Intervention

Participants did not receive periodic assessments and individualized verbal feedback.

结局指标

主要结局

Short Physical Performance Battery (SPPB)

时间窗: From enrollment to the end of the exercise program at 12 weeks.

Each test is scored on a 4-point scale, and the total score is calculated as the sum of the individual test scores, ranging from 0 to 12. Higher scores indicate better physical fitness and functional ability.

Exercise Self-Efficacy Scale (ESE)

时间窗: From enrollment to the end of the exercise program at 12 weeks.

Each item of the scale is rated on an 11-point scale, ranging from 0 (no confidence at all) to 10 (complete confidence).

次要结局

  • Timed Up and Go test (TUG)(From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.)
  • Activities-specific Balance Confidence Scale (ABC)(From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.)
  • Exercise adherence(At the end of the exercise program at 12 weeks.)
  • Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)(From enrollment to the end of the exercise program at 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Danai Paleta

Principal Investigator

University of West Attica

研究点 (1)

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