跳至主要内容
临床试验/NCT05885165
NCT05885165Unknown不适用

Supervised Online Team-based Resistance Training Versus Unsupervised Self-administered Resistance Training for Elders: a Randomized Intervention Trial

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Change in 5 times sit-to-stand

研究概览

简要总结

The primary goal of this project is to investigate whether online supervised team-based exercise training is superior for increasing functional strength in elders compared to prescribed self-administered exercise training. Secondarily, the project aims to investigate whether adherence to online supervised team-based exercise training is greater compared to prescribed self-administered training, and if online supervised team-based exercise training can increase quality of life. Finally, this project will generate more knowledge on elderly individuals' approaches and responses to physical exercise through online services. The participants will undergo a 12-week intervention where they will be performing prescribed physical exercise for 5 hours bi-weekly and complete a 3-day dietary registration three times during the study. Participants will be randomized (2:1 ratio) to two groups and will: i) undergo supervised training in groups on an online live meeting platform by trained personnel, or ii) receive prescribed exercises through an online exercise platform but their training will be self-administered and unsupervised.

研究设计

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

入排标准

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

入选标准

  • •Age ≥ 65 years.
  • •Danish reading and listening proficiency.
  • •Participant is in possession of either a computer, tablet, or smartphone in order to participate in Zoom meetings (supervised team-based group) or training programs via Exorlive (unsupervised group).
  • •The participant is able to walk independently and without external aids.

排除标准

  • •BMI > 35 kg/m
  • •Participation in other intervention studies or intention to do so, which are likely to affect the present study.
  • •Known diseases which may affect energy expenditure and/or satiation/satiety/food intake i.e. inflammatory bowel disease, thyroid diseases.
  • •Current diagnosis of eating disorder (e.g. restrained eating, disinhibition, emotional eating).
  • •Psychiatric disorders i.e. schizophrenia, bipolar disease or depression with hospitalization within the last 6 months.
  • •History or diagnosis of cardiovascular disease including current angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or hemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class II to IV); myocardiopathy; and history of aortic aneurysm ≥5.5 cm in diameter or aortic aneurysm surgery within the past six months, as diagnosed by a medical doctor.
  • •Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, stable treatment (i.e. no change in treatment, either dose, type of medication or other changes) within the last three months is required.
  • •History or diagnosis of chronic kidney disease.
  • •History or diagnosis of liver disease.
  • •Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption.
  • •Systemic treatment with glucocorticoids inhalations and creams etc. is allowed
  • •Cancer: active malignant cancer or history of malignancy within the last five years (with exception of local basal and squamous cell skin cancer).
  • •Previous bariatric surgery or intention to undergo bariatric surgery within the next 12 months.
  • •History of extensive small or large bowel resection.
  • •Known endocrine origin of obesity (except for treated hypothyroidism).
  • •Current use of prescription medication or use within the previous month that has the potential of affecting body weight such as systemic corticosteroids (excluding inhaled and topical steroids), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgment of the investigator, do not affect body weight or participation in the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the subject has been on a stable dose for at least three months.
  • •Concurrent therapy with immunosuppressive drugs or cytotoxic agents.

研究组 & 干预措施

Supervised team-based exercise

Experimental

In this arm, participants will receive guided training by an instructor in teams of 10 on the online platform Zoom.

干预措施: Supervised team-based exercise (Behavioral)

Unsupervised exercise

Active Comparator

In this arm, participants will perform the training individually with the exercises provided on the platform Exorlive, which is a one-way communication platform. However, the first two weeks (5 training sessions) will be conducted in teams of 10 participants with the presence of an instructor who will introduce, demonstrate, and supervise correct form and technique and ensure understanding of the exercise concept.

干预措施: Unsupervised exercise (Behavioral)

结局指标

主要结局

Change in 5 times sit-to-stand

时间窗: Week 0 and week 13

Physical function, assessed by the '5 times sit-to-stand' (5xsts) test

次要结局

  • Change in Fat-free mass(Week 0 and week 13)
  • Change in 1 repetition maximum (RM) leg press(Week 0 and week 13)
  • Change in Fat mass(Week 0 and week 13)
  • Change in Resting blood pressure(Week 0 and week 13)
  • Change in Quality of life (RAND 36-item health survey)(Week 0 and week 13)
  • Change in Aerobic fitness(Week 0 and week 13)
  • Change in Balance(Week 0 and week 13)
  • Adherence to exercise(At every training from week 1-12)
  • Food records(Week 1, Week 6, and Week 12)

研究者

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

Faidon Magkos

Professor

University of Copenhagen

研究点 (1)

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